Canada's CADTH issues mixed reimbursement endorsements for nine drugs, including negative recommendation for BioMarin's Vimizim

Cimzia (certolizumab pegol; UCB Pharma, Belgium)

Reducing the signs and symptoms of active ankylosing spondylitis (AS) in adult patients who have had an inadequate response to conventional therapy.

List with conditions: List in a manner similar to other biologic disease-modifying anti-rheumatic drugs (DMARDs) for AS, as long as the annual drug plan costs do not exceed the annual drug plan costs of using the least costly reimbursed biologic DMARD.

At the submitted price (CAD664.51, or USD549.78, per 200 mg/mL), the annual cost of Cimzia exceeds treatment costs for AS with Simponi (golimumab; Johnson & Johnson, J&J, US; +CAD1,028) and Humira (adalimumab; AbbVie, US; +CAD21), but is less costly than Enbrel (etanercept; Amgen, US; -CAD1,048), branded Remicade (infliximab; J&J; -CAD20,231 to -CAD12,331), and biosimilar infliximab (-CAD6,729 to -CAD1,529) for the first year of treatment. See full report here.

Cimzia

Alone or in combination with methotrexate (MTX) for reducing signs and symptoms as well as inhibiting the progression of structural damage in patients with moderate to severe active psoriatic arthritis (PsA) who have failed one or more DMARD.

List with conditions: List in a manner similar to other biologic DMARDs, as long as annual drug plan costs for Cimzia for PsA do not exceed the annual drug plan cost with the least costly reimbursed biologic DMARD.

At the submitted price, the annual cost of Cimzia for PsA is CAD19,271 in the first year, which is more costly than Simponi (+CAD1,028) and Humira (+CAD21), but less than Enbrel (-CAD1,048), Remicade (-CAD12,331), biosimilar infliximab (-CAD1,529), and Stelara (ustekinumab; J&J; -CAD3,695), based on publicly available prices. Ssee full report here.

Esbriet (pirfenidone; Roche, Switzerland)

Treatment of adults with mild to moderate idiopathic pulmonary fibrosis (IPF).

List with conditions: List to treat mild to moderate IPF (forced vital capacity, FVC) greater than or equal to 50% of predicted levels. Patients should be under the care of an experienced specialist and have stable disease (no = 10% FVC decrease in last 12 months), before and throughout treatment. A substantial price reduction is also required.

Based on the agency's estimated incremental cost-utility ratio (ICUR) for Esbriet versus best supportive care (BSC) of CAD137,000 per quality-adjusted life year (QALY), the CDEC concluded that Esbriet is not a cost-effective treatment option at the submitted price of CAD12.77 per capsule or CAD115.00 per day. See full report here.

Triumiq (dolutegravir + abacavir + lamivudine; ViiV Healthcare, US)

Treatment of human immunodeficiency virus (HIV-1) infection in adults.

List with conditions: List in a manner similar to other HIV-1 treatment regimens.

At the submitted price, Triumiq (CAD41.01 per day) is less costly than the individual components (CAD42.12 per day) and less costly than other recommended first-line, single-tablet regimens, including Gilead Sciences (US)'s Atripla (efavirenz + tenofovir +emtricitabine), Complera (emtricitabine + rilpivirine + tenofovir), and Stribild (cobicistat + elvitegravir + emtricitabine + tenofovir), with cost savings ranging from CAD1 to CAD5 daily. See full report here.

Xeljanz (tofacitinib; Pfizer, US)

Alone or in combination with MTX, for reducing the signs and symptoms of rheumatoid arthritis (RA) in adult patients.

List with conditions: Patients need to have demonstrated an inadequate response or intolerance to non-biologic DMARDs. List in a similar manner to biologic DMARDs and daily dosage should not exceed 10 mg. Drug plan costs for tofacitinib should not exceed that of other reimbursed biologic DMARDs.

At the submitted price of CAD23.10 per 5 mg tablet (CAD46.19 per day), treatment with Xeljanz was more costly than biosimilar Inflectra (infliximab; Hospira, US), and Actemra (tocilizumab; Roche, Switzerland), with incremental costs ranging from CAD1,272 to CAD8,718 in the first year of treatment for patients weighing 70 kg. However, compared with Humira, Cimzia, Enbrel, Simponi, Remicade, Kineret (anakinra; Sobi, Sweden), Orencia (abatacept; Bristol-Myers Squibb, BMS, US), and two courses of rituximab, Xeljanz would generate savings ranging from CAD495 to CAD6,829 in the first year of treatment. See full report here.

Aptiom (eslicarbazepine acetate; Sunovion Pharmaceuticals, US)

Adjunctive therapy for partial-onset seizures in patients with epilepsy who are not adequately controlled with conventional therapy.

List with conditions: Patients should be under the care of an experienced physician and on two or more antiepileptic drugs (AEDs), and for whom less costly AEDs are ineffective or contraindicated. The daily cost of treatment with Aptiom should not exceed the daily cost of alternative adjunctive therapies.

At the undisclosed submitted price, treatment with Aptiom is less costly than other adjunctive AEDs, including Vimpat (lacosamide; UCB Pharma; CAD7.06 per day) and Fycompa (perampanel; Eisai, Japan; CAD9.45 per day). See full report here.

Zaxine (rifaximin, Salix Pharamceuticals, US)

Reducing the risk of overt hepatic encephalopathy (HE) recurrence.

List with conditions: Zaxine should be used in combination with a maximal tolerated dose of lactulose, in patients with inability to achieve adequate control of HE recurrence with lactulose alone.

At the reduced submitted price (CAD15.36 per day), the ICUR for Zaxine plus lactulose compared with lactulose alone ranges from being dominant to CAD22,571 per QALY. At the recommended dose of 550 mg twice daily, based on the reduced price, the annual cost of rifaximin is CAD5,605. See full report here.

Afinitor (everolimus; Novartis, Switzerland)

Treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) who are not candidates for surgical resection.

Do not List

The cost-effectiveness of Afinitor for SEGA is uncertain. According to CADTH, the pharmacoeconomic evaluation submitted by Novartis is limited by the absence of clinical data regarding the effect of Afinitor on clinically meaningful endpoints. The annual cost of treatment range from CAD69,927 to CAD104,890 based on patient size. See full report here.

Juxtapid (lomitapide; Aegerion Pharmaceuticals, US)

Reduce low-density lipoprotein cholesterol (LDL-C) in adult patients with homozygous familial hypercholesterolemia (HoFH).

Do not list

CDR analysis suggests that the annual cost per HoFH patient treated with Juxtapid would be CAD310,132, compared with the annual cost of treatment with standard of care (lipid-lowering therapy with or without plasma exchange) at CAD14,339. Ssee full report here.

Vimizim (elosulfase alfa; BioMarin Pharmaceutical, US)

Treatment of mucopolysaccharidosis (MPS) IVA patients.

Do not List

CDR re-analysis of BioMarin's cost-effectiveness analysis resulted in an ICUR of CAD2.96 million per QALY versus BSC and CAD6.16 million per QALY if no stopping rule is implemented. A 90% price reduction of elosulfase alfa would lead to an ICUR of CAD308,995 per QALY versus BSC. See full report here.