pharmafile | December 7, 2009 | Feature | Research and Development |
The drug, an anti-viral for use in chronic infections, was the newest in its class. Historically, the mainstay of therapy had been a cheaper drug in the same class which was associated with high rates of resistance. Newer drugs had been developed which were associated with lower rates of resistance, but were generally more expensive. The potency with regard to reducing viral load appeared to vary between drugs. There were very few head to head trials between the client’s drug and the newer drugs in the class. Consequently, there was no clear understanding of which drug was the most clinically or cost-effective option and which sequence of drugs was preferential.
Initially a scoping exercise was undertaken to identify potential arguments/objections for the drug in question. This involved the examination of key papers and expert interviews. Abacus then conducted a large scale systematic literature review to identify papers relevant to the client’s drug and four comparator anti-virals as monotherapy or as part of various combinations or sequential regimens. A complex meta-analysis was employed using high-end mixed treatment comparison statistical techniques. The analysis demonstrated that the client’s drug was the most potent drug in the class for treatment of the infection. Abacus constructed a Markov model to demonstrate the long term impact that anti-viral resistance had on clinical outcomes, in particular liver damage. The model showed that our client’s drug was the most cost-effective choice among 1st line options for treatment-naive patients and among 2nd line options for patients who had developed resistance to current 1st line therapy.
Having established clinical and cost effectiveness arguments, Abacus then drafted various HTA dossiers, including SMC, NICE, AWMSG and CDR.
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