HTB South

NHS England approves four-in-one Stribild (Quad) for limited use

Simon Collins, HIV i-Base

On 11 September, NHS England issued a policy statement for a single tablet, four-in-one HIV combination treatment called Stribild (also know as Quad). [1]

This is important as Stribild is the first HIV treatment to be reviewed under the new NHS structure for commissioning HIV care.

The commissioning position, effective from August 2013, states the following scenarios in which it will be routinely funded:

  • In ARV experienced patients with no prior history of virological failure or drug resistance, and who require a switch from their current regimen where there is a clinical advantage of Stribild over alternative switch options and where the use of the individual components is not contraindicated. OR
  • In ARV-naïve patients with high viral loads who are not suitable for NNRTIs (or others on NNRTI who need to switch for reasons unrelated to resistance). AND
  • Where the decision to prescribe Stribild has been taken after review in a Multidisciplinary HIV specialist treatment meeting and that this will be subject to clinical and commissioner audit. AND
  • Where Stribild prescribing is no greater than 5% of the patients in a clinical cohort on treatment.

The combination was approved by the US FDA in December 2012 and by the EMA in May 2013. [2, 3]

The four drugs in Stribild are an integrase inhibitor (elvitegravir 150 mg) a pharmockinetic booster (cobicistat 150 mg), FTC (emtricitabine 200 mg) and tenofovir DF (300 mg).

Stribild needs to be taken once-daily with food. It should not be started in patients with estimated creatinine clearance below 70 mL per minute.

For further details please refer to the full prescribing information and patient information leaflets on the EMA website. [4]

Comment

As the first new ARV to receive EU approval under the current NHS restructuring, this is broadly good news for HIV positive people.

It shows that a new treatment can be reviewed and available relatively soon after European approval. It also recognises that new drugs have more limited data and therefore the requirement for a case review, by a team with experience of complex cases, is also probably good.

It is likely that these recommendations were closely related to the negotiated price that is referred to in the document but not given. The UK list monthly price for Stribild is £1034.72 (ex-VAT) so the discounted price is likely to be significantly lower – though the lack of transparency over actual drug costs is perhaps not in patient interests.

References:

  1. NHS England. Clinical Commissioning Policy Statement: Stribild for the treatment of HIV-1 infection in adults: 11 September 2013. Document reference B06/PS/a.
    http://www.england.nhs.uk/wp-content/uploads/2013/09/b06-psa.pdf (PDF)
  2. FDA press release: FDA approves new combination pill for HIV treatment for some patients. (27 August 2012).
    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317004.htm, Gilead press release.
  3. European Commission Approves Stribild, a New Single Tablet Regimen for the Treatment of HIV-1 Infection. (28 May 2013).
    http://www.gilead.com/news/press-releases/2013/5/european-commission-approves-stribild-a-new-single-tablet-regimen-for-the-treatment-of-hiv1-infection
  4. Stribild. Summary of Product Characteristics – Full prescribing information.
    http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002574/human_med_001654.jsp&mid=WC0b01ac058001d124

Links to other websites are current at date of posting but not maintained.