| Table 1: Targeted Immune Modulators Included in the ICER Report | |
| High Certainty of FDA-Approved TIMS | · Adalimumab
· Certolizumab pegol ad goes here:advert-1 ADVERTISEMENT SCROLL TO CONTINUE · Etanercept · Golimumab ad goes here:advert-2 ADVERTISEMENT SCROLL TO CONTINUE · Infliximab · Abatacept · Rituximab · Tocilizumab · Tofacitinib |
| Investigational TIMs (awaiting FDA approval) | · Sarilumab
· Baricitinib |
The report found that all TIMs provide a substantial net benefit when combined with conventional DMARDs—compared with DMARDs alone—in people with moderate to severe RA. When looking at head-to-head studies that compared the clinical effectiveness between specific TIMs (adalimumab was the most commonly used TIM as comparator), the report found more modest benefits between the TIMs (Table 2). For TIMs that were not compared in head-to-head studies, the report stated that there was insufficient evidence to differentiate the therapies.1
| Table 2: Head-to-Head Comparisons of TIMs: Findings | |
| Monotherapy Regimens | Incremental or better net benefit found with sarilumab monotherapy and intravenous tocilizumab monotherapy compared to adalimumab monotherapy. |
| Combination Regimens (with Conventional DMARDs) | Comparable net health benefits found between regimens involving tofacitinib, subcutaneous abatacept, certolizumab pegol and etanercept, and regimens involving adalimumab plus methotrexate.
Comparable or better net health benefit found in a single trial of combination therapy with baricitinib compared with adalimumab. |
When looking at the comparative value among TIMs, the report found that none of the 11 TIMs were considered cost effective based on a formula that establishes a reasonable value on a therapy when the cost per quality-adjusted life year (QALY) is between $50,000 and $150,000. All of the TIMs were found to be above that cost threshold.3
To calculate cost, the report used a model based on a sequential treatment pattern in which patients who fail to respond (based on ACR20) to a TIM after six months can switch to another TIM up to three times. After the third failure, the fourth and final treatment option is called palliative care—meaning treatment with conventional DMARDs.1
Finally, the report provided a number of key policy recommendations:
- Consider including in prior authorization processes the requirement that conventional DMARD therapy dosing be optimized before initiating TIM therapy;
- If step therapy protocols require patients to fail one or two TNFα inhibitors before switching to another TIM, develop a quick and transparent exception process for specific situations;
- Payers should reach out to providers to learn from their experience with prior authorization to streamline and improve the process;
- Reconsider step therapy if pricing becomes better aligned with clinical value;
- Negotiate better rebates, and share savings with patients;
- Increase transparency around the role of discounting and rebate practice in formulary design; and
- Design innovative risk-sharing payment agreements, including pay-for-performance contracts, value-based contracts and indication-specific pricing.
Specific Concerns of Cost-Effectiveness Findings
Although the recommendation includes a number of policy recommendations encouraging patient access, Dr. Tindall remains concerned that the cost-effectiveness conclusions of the ICER report will be used by insurance companies to justify restricted formularies, step therapy, medication switching and coverage denials for many FDA-approved RA therapies. “This will make it more difficult for patients to access the care they need,” she says.