Lately, we seem to have heard nothing but bad news from across the pond with the National Institute for Clinical Effectiveness (NICE) seemingly rejecting approval for reimbursement of many new cancer drugs, causing an outcry in the physician and patient communities alike.  One such example was the recent rejection of the second generation tyrosine kinase inhibitors (TKIs), dasatinib (Sprycel) and nilotinib (Tasigna) after failure of imatinib (Glivec) in chronic myeloid leukemia (CML).

However, this morning I heard from industry friends that actually, NICE has finally approved something without too much drawn out hassle.

The drug?

PharmaMar/J&J's trabectedin (Yondelis) in soft tissue sarcomas.

Interestingly, the same drug is getting a rather rough ride with the FDA and ODAC in ovarian cancer over here in the US, but anecdotally, I have heard from several oncologists who participated in the EU trials that the drug has a role to play in refractory STS given the lack of choices beyond ifosfamide based regimens.

So, what can we learn from the NICE decision, especially given that J&J also managed to obtain reimbursement for Velcade in the UK?

It is clear that companies not only need to show some pharmacoeconomic benefit, but also offer some discount or incentive for the cash strapped NHS to see a bargain.  J&J made a creative deal whereby they would cover the cost of bortezomib (Velcade) in cases where the drug did not work, so the NHS would only pay for those that did. 

What happened in this case? 

NICE originally issued draft guidance earlier this year not recommending trabectedin
for use on the NHS due to its high cost.  According to the final appraisal document published on Dec 21st, a workable solution had been hammered out:

"Trabectedin is recommended as a treatment option for people with advanced soft tissue sarcoma if:

  • treatment with anthracyclines and ifosfamide has failed or
  • they are intolerant of or have contraindications for treatment with anthracyclines and ifosfamide and
  • the acquisition cost of trabectedin for treatment needed after the fifth cycle is met by the manufacturer."

All in all, that seems a fair enough solution with a win-win for everyone involved.  In 2010, we may well see more sensible approaches like this with some flexibility to work towards compromise on both sides. Drug companies are learning that they can't just charge what they like willy nilly expecting approval based on limited resources and NICE is learning to be creative in seeking effective solutions to increase patient access to new therapies that may make a difference to their daily lives.

Who knows, the US may well gravitate towards the inclusion of cost-effectiveness measures in decision making over the next 2-3 years as well.

Reblog this post [with Zemanta]