- All but one of the disease-modifying treatments currently on the market for the most common form of multiple sclerosis (MS) are overpriced when compared to a value-based benchmark, according to a final report released this week by the Institute for Clinical and Economic Review.
- Sanofi's Lemtrada (alemtuzumab) was the only drug to check in under ICER's cost-effectiveness threshold of $150,000 per quality-adjusted life year (QALY) — a frequently used, but sometimes controversial, standard that takes into account a drug's price, efficacy, safety and other costs.
- ICER's review found many of the other drugs studied, such as Novartis Gilenya (fingolimod) or Biogen's Tysabri (natalizumab), to lower relapse rates and slow disease progression for patients with relapsing/remitting MS. But high relative costs, as well as mixed efficacy results compared to generic glatiramer acetate, meant lower cost-effectiveness scores for most.
ICER's newest cost-effectiveness report is unlikely to win it any new friends in the pharmaceutical industry.
The non-profit research group has sparred in the past with the industry, which has generally taken a dim view of ICER's attempt to quantify drug value. Previous reports on treatments for hepatitis C, high cholesterol and multiple myeloma have found many well-known brands to be priced above cost-effectiveness benchmarks.
Drugmakers have argued ICER's reviews are driven by the interests of insurers and fail to take the patient perspective into account. In response, the group has pushed back publicly, attempting to rebut many of the claims made by disgruntled drugmakers.
ICER also recently revised its value assessment framework, building on feedback and comments from patients and payer groups as well as the industry. The range for cost-effectiveness ratios used in long-term value calculations, for example, was expanded, and ICER will use prices net of rebates rather than wholesale acquisition costs in its assessments going forward.
This week's report on multiple sclerosis drugs, however, still uses ICER's old framework, as the review was underway before the revisions were made.
Of the 15 approved, disease-modifying MS treatments reviewed, 12 would need discounts of more than 50% to meet the $150,000 per QALY standard.
Sanofi's Lemtrada, however, showed good value in ICER's view, compared to both supportive care and generic glatiramer acetate. Unlike the other drugs reviewed, Lemtrada doesn't require continuous dosing. Sanofi also covers the costs of laboratory monitoring, leading to lower cost-effectiveness ratios, ICER explained.
That being said, ICER cautioned against taking Lemtrada's good performance on cost benchmarks too far. The drug comes with a boxed warning for serious — sometimes fatal — autoimmune conditions, and is only available through a risk mitigation program.
ICER also reviewed Roche's ocrelizumab, which is currently undergoing review at the FDA. Expectations are high for the drug, which could be the first medication approved to treat the rarer primary progressive form of MS.
In the review, ocrelizumab scored high marks for its efficacy in lowering relapse rates and slowing disease progression for RRMS patients. ICER also deemed there to be "moderate certainty" ocrelizumab would deliver a small to substantial net benefit in primary progressive MS.
Depending on the price Roche sets, ICER's findings could be good news for the Swiss pharma's discussions with payers.