- Sanofi, Regeneron, Amgen, and Novartis have all had to rein in expectations of blockbuster sales for new drugs as payers' pricing caution has slowed uptake.
- Two new PCSK9 drugs, Sanofi/Regeneron's Praulent and Amgen's Repatha, along with Novartis' heart med Entresto all disappointed in post-launch sales, as revealed by recent quarterly earnings.
- Uptake is slow because Medicare is taking a full six months to evaluate newly approved drug. Until that review process is completed, patients have had difficulty in getting a drug even with a prescription.
Slow uptake has been an unexpected challenge for companies launching new drugs, even ones representing a major improvement in the standard of care.. However, what was once an unexpected challenge—payers imposing various restrictions on high-cost therapies—is becoming the new normal.
For example, since Novartis launched Entresto, the company has only recorded $35 million in total sales. This drug, which is priced at about $12.50 per day, or just under $4,600 per year, was subjected to a six-month review process by Medicare. Now that the review process has ended, roughly 70% of Medicare patients are expected to have access to Entresto.
Novartis pharmaceutical head David Epstein previously blamed slower reimbursement policies in the US as a factor in slowing sales of the drug.
The two PCSK9 drugs are both priced over $14,000, with rebates only in the 20% range. With generic competitors, payers have restricted access to manage cost. For these drugs, payers may be waiting for long-term outcome studies to show actual effect in the real world rather than just showing they reduce LDL-C.
It appears that even with FDA approval, drugs must demonstrate clear value before being included in the docket of reimbursable drugs.