Reimbursement restrictions have severely limited uptake of the PCSK9 inhibitors.
By Louisa Joseph, Analyst
30 May 2016
The PCSK9 inhibitors have struggled to penetrate the US dyslipidemia market due to payor’s strict reimbursement protocols over the drugs’ high yearly costs. Praluent and Repatha gained FDA approval in Q3 2015 for familial hypercholesterolemia, and for secondary-prevention patients who require further LDL-C lowering, in spite of maximally tolerated statin therapy. However, at high annual costs of ~$14,000 per patient (though discounts are negotiated) and without the availability of outcomes data, payers have put strict restrictions on the availability of the PCSK9 inhibitors. In order to gain access to the drugs, prescribing physicians have to go through complicated and lengthy prior authorization processes which require filling out multiple pages of handwritten data. Many requests are later denied on the basis of improper completion of these documents. Furthermore, Praluent and Repatha are associated with high levels of co-pay, which force patients to either pay for a large proportion of the treatment themselves, or opt for a cheaper alternative. These restrictions have severely limited the availability of Praluent and Repatha in the US, with even the most high-risk dyslipidemia patients struggling to gain access to the costly medications.
Datamonitor Healthcare’s Dyslipidemia: marketed profiles cover the clinical and commercial attractiveness of currently branded therapies.
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