Drug Plan Research Articles

Sotatercept (Winrevair)

Canada’s Drug Agency (CDA-AMC) recommends that sotatercept (Winrevair) should be reimbursed by public drug plans for the treatment of patients with WHO Group 1 pulmonary arterial hypertension (PAH) if certain conditions are met. Winrevair should only be covered as add-on therapy in patients with confirmed WHO Group 1 PAH based on guidelines-approved diagnostic procedure including right-heart catheterization (RHC). Winrevair should only be reimbursed as an add-on therapy in patients who are not at low risk, currently treated with optimal background therapy for at least 3 months, and if the cost of Winrevair is reduced.

Clindamycin Plus Benzoyl Peroxide and Adapalene (Cabtreo)

It is recommended that Cabtreo be reimbursed by public drug plans for the topical treatment of acne vulgaris in patients 12 years of age and older if certain conditions are met. Cabtreo should only be covered to treat patients 12 years of age and older with acne vulgaris. Cabtreo should only be reimbursed if the price of Cabtreo is negotiated so that it does not exceed the drug program cost of treatment with topical therapy for acne vulgaris reimbursed by participating plans.

Danicopan (Voydeya)

Canada’s Drug Agency (CDA-AMC) recommends that Voydeya be reimbursed by public drug plans as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have residual hemolytic anemia due to extravascular hemolysis (EVH) if certain conditions are met. Voydeya should only be covered to treat adult patients with a diagnosis of PNH, who have met the public drug plan reimbursement criteria for initiating complement 5 inhibitor (C5i) treatments (ravulizumab or eculizumab) before receiving C5i treatment, and who have been on a stable dose of C5i treatment for 6 months or more, in addition, patients should also have persistent anemia caused by EVH, and an absolute reticulocyte count of 120 × 109/L or greater. Voydeya should only be reimbursed if prescribed by a hematologist with experience managing PNH. The cost of Voydeya should be negotiated so that Voydeya plus a C5i as a regimen does not exceed the drug program cost of treatment with pegcetacoplan for the treatment of adult patients with PNH who have residual hemolytic anemia due to EVH.

Elexacaftor-Tezacaftor-Ivacaftor and Ivacaftor (Trikafta)

Canada’s Drug Agency (CDA-AMC) recommends that Trikafta be reimbursed by public drug plans for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least 1 of the 152 non-F508del mutations in the CFTR gene that are identified in Figure 1 of this document, if certain conditions are met. Patients aged 2 to 5 years who start treatment with Trikafta should be evaluated for response after 1 year, and those aged 6 years or older should be evaluated after 6 months. The physician must provide evidence that the patient is benefiting from the treatment. The cost of Trikafta must also be reduced.

Burosumab (Crysvita)

Canada’s Drug Agency recommends that Crysvita be reimbursed by public drug plans for the treatment of X-linked hypophosphatemia (XLH) in adult patients if certain conditions are met. The previous recommendation for Crysvita when initiated in pediatric patients who are at least 1 year of age and in whom epiphyseal closure has not yet occurred, continues to apply to those patients. Crysvita should only be covered to treat patients aged 18 years or older who have a diagnosis of XLH supported by classic clinical features of adult XLH and a confirmed PHEX gene variant, and who have not previously received it. Patients should also have a specific threshold for kidney function or reduced kidney function if it is confirmed not to be due to nephrocalcinosis, bone pain that is caused by XLH or osteomalacia, and have not had a sufficient response to conventional therapy (therapy with active vitamin D and oral phosphate). If a PHEX gene variant is not confirmed, XLH diagnosis can be confirmed with a serum intact fibroblast growth factor 23 (FGF23) level by a Kainos assay. Crysvita should only be reimbursed if it is prescribed by a physician who works in a comprehensive team of health care providers experienced in the diagnosis and management of XLH and if the cost of Crysvita is reduced. Reimbursement may be renewed on an annual basis for patients who do not meet any of the discontinuation criteria, which are the development of hyperparathyroidism, nephrocalcinosis, fasting hypophosphatemia, or fractures or pseudofractures based on X-ray.

Ivosidenib (Tibsovo)

We recommend that Tibsovo in combination with azacitidine be reimbursed by public drug plans for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an IDH1 R132 mutation who are not eligible to receive intensive induction chemotherapy, if certain conditions are met. Tibsovo in combination with azacitidine should only be covered to treat adult patients with newly diagnosed AML with an IDH1 R132 mutation who are considered ineligible for standard intensive induction chemotherapy and are aged at least 75 years; have an Eastern Cooperative Oncology Group (ECOG) performance status of 2; have severe organ dysfunction in the heart, lungs, kidneys, or liver; and/or have any other comorbidity judged to be incompatible with intensive induction chemotherapy. Tibsovo in combination with azacitidine should only be reimbursed if prescribed by clinicians with expertise in managing patients with AML in a specialized hematology or oncology clinic, and the treatment should be supervised and delivered in institutions with expertise in systemic therapy delivery. The total drug cost of ivosidenib plus azacitidine should not exceed that of venetoclax plus azacitidine. Lastly, it must be feasible to test patients for IDH1 R132

Pembrolizumab (Keytruda)

Canada’s Drug Agency recommends that Keytruda should be reimbursed by public drug plans for the treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2) negative gastric or gastroesophageal junction (GEJ) adenocarcinoma if certain conditions are met. Keytruda should only be covered to treat patients who have not received previous treatment for HER2-negative advanced or metastatic gastric or GEJ cancer and who have good performance status. Keytruda should only be reimbursed if prescribed in combination with fluoropyrimidine- and platinum-containing chemotherapy by a clinician with expertise and experience in treating gastric and GEJ cancer, and the cost of Keytruda in combination with chemotherapy is reduced so that it does not exceed the drug program cost of treatment with nivolumab in combination with chemotherapy.

Osimertinib (Tagrisso)

Canada’s Drug Agency (CDA-AMC) recommends that Tagrisso in combination with pemetrexed and platinum-based chemotherapy should be reimbursed by public drug plans for the first-line treatment of patients with locally advanced (not amenable to curative therapies) or metastatic non–small cell lung cancer (NSCLC) which harbours epidermal growth factor receptor (EGFR) exon 19 deletions (Ex19del) or exon 21 (L858R) substitution mutations if certain conditions are met. Tagrisso plus chemotherapy should only be covered to treat adult patients (aged ≥ 18 years) who have nonsquamous NSCLC; whose tumours have spread to other parts of the body, returned after treatment, or cannot be removed by surgery or radiation; whose tumours harbour EGFR Ex19del or L858R substitution mutations; and who are in relatively good health. Tagrisso should not be covered to treat patients who have a history of breathing difficulties caused by scarring and inflammation in the lung tissue; who have a history of heart problems associated with their heart taking longer to recharge between beats or their heart beating too fast, too slow, or in an irregular way; or, who have already been treated for NSCLC with treatments affecting their entire body (except for treatments given at least 6 months before the tumour returned, as a first step to shrink a tumour before the primary treatment, or as an additional treatment after the primary treatment to lower the risk of the tumour returning). Tagrisso should only be reimbursed if it is prescribed in combination with pemetrexed and platinum-based (i.e., cisplatin or carboplatin) chemotherapy by clinicians with expertise in treating NSCLC, and the cost of Tagrisso is reduced. Reimbursement of Tagrisso plus chemotherapy should be discontinued if a patient’s cancer grows or spreads, or if treatment is unacceptably toxic to the patient.

Abemaciclib (Verzenio)

Canada’s Drug Agency recommends that public drug plans reimburse Verzenio in combination with endocrine therapy for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early-stage breast cancer at high risk of recurrence based on clinicopathological features if certain conditions are met. Verzenio, in combination with endocrine therapy, should only be covered in patients whose breast cancer has receptors for the estrogen and progesterone hormones, tests negative for the HER2 protein, has been removed by surgery, and is at high risk of coming back based on clinicopathological features, including 4 or more positive axillary lymph nodes (ALNs), or 1 to 3 positive ALNs plus histologic grade 3 disease, or 1 to 3 positive ALNs plus a tumour size of 5 cm or more, or 1 to 3 positive ALNs plus a Ki-67 score of 20% or more (if tumour size is < 5cm and disease is not grade 3). Verzenio, in combination with endocrine therapy, should only be reimbursed if prescribed by clinicians with expertise delivering systemic treatment and if the cost is reduced.

Financial realities of fighting cancer: A close look at patient responsibility with part D coverage.

12 Background: Medicare Part D, a prescription drug plan offered by government-contracted private payers, provides coverage for prescription drugs. The plan design encompasses the deductible, initial coverage (IC), coverage gap (CG), and catastrophic coverage (CC) phases. In the earlier phases, patients bear a significant financial burden for drug costs (100% of the deductible, 25% of drug costs during IC and CG) until they reach the out-of-pocket threshold (OOPT) and transition to the CC phase, where the responsibility decreases to 5% of the drug cost with no upper limit. Additionally, Medicare subsidizes or assumes full responsibility for low-income patients through the Low-Income Cost Subsidy (LICS) benefit. We analyzed the patient responsibility (PR) for cancer patients under Medicare Part D and the impact of Part D Anti-Neoplastics (PDAN). Methods: Using Medicare Part D prescription data for 15 practices in The US Oncology Network, we obtained and evaluated the gross drug costs below (GDCB) and above (GDCA) the OOPT, LICS and estimated PR for prescriptions over a 6-year period (July 2016 – June 2022). Results: The analysis of 5.12 million prescriptions for 99,623 cancer patients reveals that 1 in every 5 patients surpassed the OOPT and transitioned to the CC phase. Among the patients receiving PDAN drugs, 3 in every 4 crossed the OOPT. Table 1 provides the percentage of patients entering the CC phase and the estimated per patient, per year PR amounts. Within the PDAN drug recipient group, 85% of patients who reached the OOPT did so within the first 3 months of initiating therapy, often after just 2 prescription dispenses, resulting in a significant portion of the PR being incurred upfront. Approximately 45% of the PR was accumulated prior to crossing the OOPT. Interestingly, only 1 in every 5 patients receiving generic PDAN drugs surpassed the OOPT, in contrast to every patient receiving a branded PDAN. Additionally, patients receiving generic PDAN incurred lower PR costs. About 1 in every 6 patients benefited from the LICS, with 60% of the LICS amounts being paid within the first 3 months of starting therapy, aligning with the timing of patients entering the CC phase. Conclusions: Cancer patients, particularly those taking PDAN drugs, face significant PR costs. The proposed changes to the Part D plan design outlined in the Inflation Reduction Act (IRA) aim to alleviate this burden by reducing PR. These changes include reducing PR in the CC phase to 0%, capping PR in the earlier phases at $2000 and changing cost-sharing between plans, manufacturers, and Medicare. However, the potential effects of these adjustments on Part D plan premiums remain uncertain and require further examination. Without PDAN Drugs With PDAN Drugs Total % of patients Not crossing OOPT 94% 22% 80% Crossing OOPT 6% 78% 20% Patient Responsibility for Patients Not crossing OOPT $292 $1,787 $373 Crossing OOPT $2,448 $6,525 $5,555 Total $422 $5,489 $1,424

Secukinumab (Cosentyx)

It is recommended that Cosentyx be reimbursed by public drug plans for the treatment of adult patients with moderate to severe hidradenitis suppurativa (HS) (acne inversa) who have responded inadequately to conventional systemic HS therapy only if certain conditions are met. Cosentyx should only be covered to treat patients who have moderate to severe HS (Hurley stage II or III), a total abscess and nodule count of 5 or greater, and lesions in at least 2 separate areas of the body. Additionally, these are patients whose HS did not adequately respond to conventional therapy. Cosentyx should only be reimbursed if prescribed by a physician experienced in the management of HS but should not be reimbursed if used in combination with other biologic therapies for HS. Cosentyx should be reimbursed for ongoing treatment if there is improvement in HS after starting treatment with Cosentyx. The price of Cosentyx should be negotiated so that its total drug cost does not exceed the total drug cost of treatment with the lowest-cost adalimumab.

Vertical Integration and Care Experiences Among Medicare Advantage Beneficiaries

Medicare Advantage (MA) beneficiaries are increasingly enrolling in integrated MA plans. Legacy-integrated plans share unique features that may differ from newer integrated MA plans. It is unclear whether integrated and legacy-integrated MA plans are associated with a better beneficiary care experience compared with non-legacy-integrated and nonintegrated MA plans. To assess whether enrollment in integrated, legacy-integrated, non-legacy-integrated, and nonintegrated MA plans is associated with better beneficiary care experiences. This cross-sectional study included MA beneficiaries who responded to Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys conducted annually between 2015 and 2019. Data analysis was performed between October 1, 2023, and July 31, 2024. Medicare Advantage plan integration status, categorized as integrated, legacy-integrated, non-legacy-integrated, and nonintegrated. The CAHPS surveys assessed 9 care experience measures. To assess differences in care experience measures, mixed linear regression analyses were performed, adjusting for demographic characteristics, plan random effects, and state fixed effects. The sample consisted of 857 695 respondents. Their mean (SD) age was 72.6 (10.3) years, and 58.1% were women. A total of 12.7% of respondents were Black, 10.7% were Hispanic, and 71.0% were White. Compared with respondents in nonintegrated MA plans, respondents in integrated MA plans were younger (mean [SD] age, 72.7 [10.3] vs 72.2 [10.3] years, respectively) and were less likely to be Black (13.1% vs 11.2%, respectively), female (58.4% vs 57.2%, respectively), and partially dual eligible (8.7% vs 6.2%, respectively). Integrated MA plans were associated with meaningfully better mean ratings only of customer service (1.6 points [95% CI, 1.1-2.1]) and health plan (1.0 points [95% CI, 0.6-1.5]) compared with nonintegrated MA plans. Legacy-integrated MA plans were associated with meaningfully better mean ratings of drug plan (3.7 points [95% CI, 2.4-5.0]), health plan (3.1 points [95% CI, 1.7-4.5]), customer service (2.8 points [95% CI, 1.3-4.4]), getting appointments and care quickly (2.6 points [95% CI, 1.2-4.0]), health care quality (1.9 points [95% CI, 1.0-2.7]), physicians who communicate well (1.1 points [95% CI, 0.4-1.8]), and care coordination (1.1 points [95% CI, 0.4-1.9]) compared with nonintegrated MA plans. In this study, integrated MA plans were not associated with better beneficiary care experiences compared with nonintegrated MA plans. Legacy-integrated MA plans were associated with higher ratings on all care experience measures compared with both non-legacy-integrated and nonintegrated MA plans. Monitoring of integrated MA plans is needed to assess whether they are adding meaningful value to MA beneficiaries and to determine their effects on the health care system.

Cluster B personality disorders and psychotropic medications: a focused analysis of trends and patterns across sex and age groups.

This study investigated sex and age differences in patterns of psychotropic medication use before and after the initial diagnosis of Cluster B personality disorders (PDs) and analyzed trends over time. Analyzing data from the Quebec Integrated Chronic Disease Surveillance System for individuals newly diagnosed with Cluster B PD (≥ 14 years) between 2002 and 2018 and under the provincial public drug plan, we calculated yearly and monthly proportions of individuals exposed to psychotropic medications during the year before and after their diagnosis by sex and age. Robust Poisson regression models assessed the association between sex and exposure to psychotropic medications after the diagnosis of Cluster B PD. Among 87,778 individuals with a first Cluster B PD diagnosis (mean age: 44.5 years; 57.5% women), the proportion of users increased post-diagnosis. Notably, after diagnosis, females were more likely to receive psychiatric medications (between 78.9% and 83.7% during the study period vs. 72.8% and 76.8%). Males were less likely than females to receive antidepressants (adjusted prevalence ratio (aPR): 0.83; 99% confidence interval (CI): 0.82-0.85) and anxiolytics (aPR: 0.86; 99%CI: 0.84-0.88), whereas they had higher exposure to antipsychotics (aPR: 1.04; 99%CI: 1.02-1.06) and ADHD medications (aPR: 1.14; 99%CI: 1.07-1.2). Age-specific trends showed increased ADHD medication use among younger patients (14-24 years), and anxiolytic use predominated in those aged ≥ 65 years. Psychotropic medication use was high among Cluster B PD patients, with differences in medication classes according to age and sex. The marked sex and age differences in psychotropic medication use among Cluster B PD patients underscore the need for a sex-sensitive and age-specific approach in psychiatric care.

Examining The Care Pathways Patients Experience When Accessing Outpatient Psychiatric Care in British Columbia

The British Columbia (BC) mental health roadmap prioritizes equitable access to care. This study investigates the equity of care pathways experienced by BC residents accessing outpatient psychiatric care for the first time. Community-based care pathways are paramount as they indicate timely access to care and are less expensive for the health system. We analyzed linked administrative BC health data spanning April 1st 2013, to March 31st 2022, to study how sociodemographic factors relate to accessing psychiatric care pathways. Pathways to outpatient psychiatric care include a community-based pathway, hospitalization to primary care to outpatient psychiatry, and hospitalization directly to outpatient psychiatry. Sociodemographic factors considered were administrative sex, immigration recency and status, neighbourhood income quintile and being a recipient of a low-income drug plan. These relationships were analyzed using multinomial logistic regression, adjusting for age, location, fiscal year, and stratifying by mental disorder diagnoses. Being male, a low-income drug plan recipient, living in a lower income neighbourhood, or being a recent economic immigrant or permit holder was associated with increased odds of accessing outpatient psychiatric care via either hospitalization pathway. Having a diagnosis of schizophrenia/bipolar disorder was independently associated with both hospitalization pathways, and this diagnosis exacerbated the magnitude of the estimates for the sociodemographic characteristics. We find clear disparities in pathways to accessing outpatient psychiatric care. These disparities indicate health system failures in addressing specific population needs, highlighting the importance of targeted interventions, such as increasing the number of community health workers, to achieve equitable mental health care in BC.

Cabotegravir (Apretude)

CADTH recommends that Apretude should be reimbursed by public drug plans for at-risk adults and adolescents aged 12 years and older and weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection, if certain conditions are met. Apretude should only be covered by public drug plans in a similar manner to tenofovir disoproxil fumarate–emtricitabine (TDF-FTC) for of HIV-1 PrEP. Apretude should only be reimbursed if there is a reduction in price and if the economic feasibility of the adoption of Apretude is addressed.

Etrasimod (Velsipity)

CADTH recommends that Velsipity be reimbursed by public drug plans for the treatment of adults with moderately to severely active ulcerative colitis (UC) whose disease had an inadequate response or lost response, or who were intolerant, to either conventional therapy or an advanced treatment, if certain conditions are met. Velsipity should only be covered to treat adults with moderately to severely active UC whose disease has had an inadequate response or lost response, or who were intolerant, to either conventional therapy or an advanced treatment provided that it is covered for a similar patient population and in a similar way to other advanced therapies for UC (e.g., biologics, sphingosine 1-phosphate receptor modulators, or Janus kinase [JAK] inhibitors) currently reimbursed by public drug plans. Velsipity should only be reimbursed if it is prescribed by a physician experienced in the diagnosis and management of UC, if it is not used in combination with other advanced therapies for UC, and if the cost is reduced so that it does not cost the drug programs more than the least costly relevant advanced therapy. A patient’s disease must respond to the treatment in the first 12 weeks of starting Velsipity to continue receiving the drug.

Evolocumab (Repatha)

It is recommended that Repatha be reimbursed by public drug plans for the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in adult patients with primary hyperlipidemia (atherosclerotic cardiovascular disease [ASCVD]) if certain conditions are met. Repatha should only be covered to treat patients with a recent acute coronary syndrome (ACS) event, defined as those who have been hospitalized for a heart attack or unstable angina in the past 52 weeks. Additionally, these are patients with an LDL-C level between 1.8 mmol/L and 2.2 mmol/L (inclusive) or a non–high-density lipoprotein cholesterol (non–HDL-C) level between 2.6 mmol/L and 2.9 mmol/L (inclusive) or an apolipoprotein B (ApoB) level between 0.7 g/L and 0.8 g/L (inclusive), despite receiving the highest dose of statin that can be tolerated and ezetimibe. Alternatively, these are patients with an LDL-C level greater than 2.2 mmol/L, a non–HDL-C greater than 2.9 mmol/L, or an ApoB greater than 0.8 g/L, despite receiving the highest dose of statin that can be tolerated, with or without ezetimibe. Repatha should only be reimbursed if prescribed by a cardiologist or internal medicine specialist with expertise in the post-ACS setting and if the cost of Repatha is reduced. Repatha should not be reimbursed for use in combination with other PCSK9 inhibitors.

Relugolix (Orgovyx)

CADTH recommends that relugolix (Orgovyx) should be reimbursed by public drug plans for the treatment of advanced prostate cancer if certain conditions are met. Orgovyx should only be covered to treat adult patients who have advanced prostate cancer and are not candidates for chemotherapy or surgical therapy soon after initiating treatment. Orgovyx should only be reimbursed if it is prescribed by a clinician with expertise in managing prostate cancer. The cost of Orgovyx should not exceed the drug program cost of treatment with the least costly alternative treatment. Orgovyx should be stopped if the patient experiences severe side effects.

Atogepant (Qulipta)

CADTH recommends that atogepant (Qulipta) be reimbursed by public drug plans for the prevention of migraine if certain conditions are met. For migraine prevention, Qulipta should only be covered in adult patients who have tried at least 2 other types of treatments for the prevention of migraine. Qulipta should only be reimbursed if it is prescribed by a prescriber with experience managing chronic migraine (CM) headaches and if the cost of Qulipta is not more than the least costly calcitonin gene–related peptide (CGRP) inhibitor currently funded for this population. Qulipta should not be reimbursed for use in combination with other CGRP inhibitors for the prevention of migraine in adult patients with CM.

Pembrolizumab (Keytruda)

CADTH recommends that public drug plans reimburse Keytruda for the treatment of locally advanced unresectable or metastatic biliary tract carcinoma (BTC) if certain conditions are met. Keytruda in combination with gemcitabine-based chemotherapy should only be covered to treat patients with locally advanced unresectable or metastatic BTC who have not received prior treatment or who have completed treatment with nongemcitabine-based neoadjuvant or adjuvant therapy more than 6 months ago. Patients receiving Keytruda should be in relatively good health (i.e., have a good performance status, as determined by a specialist). Keytruda should only be reimbursed if it is used in combination with gemcitabine-based chemotherapy if prescribed by specialists with experience in managing BTC and if the cost of Keytruda does not exceed the cost of durvalumab. Keytruda should not be reimbursed if it is used to treat patients with Ampulla of Vater cancer.