UK NHS Pharmaceutical Approval Body Rejects GSK’s Lupus Drug Benlysta
GSK’s new medicine for treating Lupus – Benlysta (generically known as ‘Belimubab’) was rejected by the UK National Health Service’s (NHS) drug rationing body. The drug was discovered by Human Genome Sciences and developed by Glaxo SmithKline (GSK) to combat the disease that causes the immune system to attack joints and organs.
Why the NHS rejected the drug
- According to NHS, the cost of the drug – without the discount – is more than £2,300 initially and £769.50 subsequently which equates to more than £61,000 per QALY (A Year of good Quality Life). It further accounts that, it usually rejects drugs costing more than £30,000; except in terminal illness.
- The evidence considered did not urge the NHS Committee that Belimumab (Generic – Benlysta) provided enough health benefit for patients in view of the amount it had to pay for it ,when compared to standard care, as the cost of the drug when compared with its efficacy is very high.
- The NHS further defended its decision by confirming that it had carefully viewed the evidence (considering the clinical effectiveness of the drug – ‘Benlysta’ when compared with the standard treatments available) and taken have into account the view of people and their doctors about the disease condition.
- In its final draft guidance, the NHS committee confirmed that it definitely will not recommend Benlysta (Belimumab) as an add-on therapy in patients with active autoantibody-positive systemic lupus erythematosus and those who have a high degree of disease activity, despite receiving standard therapy.
- The NHS committee also raised concerns about infection, suicide risk and complications caused by use of Benlysta in patients using concomitant or immunosuppressive medicines and queried regarding its efficacy in African and African-American patients and reduce steroid use in patients.
- The committee also pointed out that subjects enrolled in clinical trials were drawn from a very narrow population, including a low proportion of African-Americans, which was not representative of US residents.
Criteria taken into consideration for drug approval by NHS‘ pharmaceutical approval body
- A drug can be launched and prescribed only after it meets the specific criteria of the drug’s license and approved by publicly funded health care bodies like.
- A drug has to be licensed for specific stage and type of disease condition.
- Organizations like National Institute for Health and Clinical Excellence (NICE) look at the evidence on how well the drug works, on any drawbacks or limitations and on cost effectiveness of the drug before approving it.
- A fast track process has been introduced to evaluate drugs more quickly and drugs which give terminally ill patients a few extra months to live have a better chance of being approved on the NHS under new rules.
- The approval body plans to support the development of novel treatments for smaller patient groups that provide innovative benefits over and above existing NHS care.
The role of NICE in NHS drug approval
- The criteria and quality standards set by NICE are broken down by a specific disease, condition or clinical area and will also indicate when a treatment or procedure is considered efficacious, reasonable in cost and safe, as well as being viewed and accepted as a positive experience by patients.
- The treatment should have a cost-effectiveness ratio higher than the £30,000 cut-off normally used by NICE to determine good use of NHS resources and there should also be no alternative treatments with similar benefits available on the NHS.
- The population for which the drug is indicated and licensed should not normally exceed 7,000, with the intention of including medicines for rarer terminal illnesses and small groups within larger populations. This criterion is not intended to cover medicines developed for ultra orphan conditions involving very small groups of patients.
- Drug recommended for use will normally be subject to an appropriately designed programme of evidence development or studies (the design of these studies will be determined and outcome assessed, reported by NHS to ensure that the anticipated survival gains are evident when it is used in routine practice).
- According to NICE, medicines approved following the application of the supplemental advice will not necessarily be regarded or accepted as standard comparators for future appraisals of new medicines introduced for the same condition in order to ensure that a high Incremental Cost Effectiveness Ratio (ICER) does not become the standard for assessment of medicines subsequently introduced for the same indication.
- Subsequent licences for the same drug product will be considered on their individual merits and the drug rationing body will take into account, the cumulative population for each product for justifying a higher ICER.
- Any treatment to meet the criteria must be for patients with a short life expectancy, normally less than 24 months and there must be sufficient evidence that extends life, usually at least an additional three months, compared with current NHS treatment .
NICE has extended the threshold at which the drugs are deemed cost-effective but this applies to people suffering from terminal illnesses. Changes have been made by NHS to the appraisal process for the use of life-extending treatments licensed for terminal illnesses which following appraisal will be ones that the drug approval committee will decide to offer demonstrable survival benefits over current NHS practice. This step implies that those treatments which were previously considered as expensive for routine use in the NHS might now be recommended for use.
Mixed response from industry experts:
Experts from the industry opine that NHS should not compare ‘Belimumab’ to cheap, older medicines that are now out of patent and should recognise the benefit of this clinically proven medicine, as the disease is currently uncontrolled by existing therapies. According to them ‘Benlysta’ when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease. Funded studies on the drug showed that 43 percent of patients who were given a high Benlysta dose with standard therapies felt relief, and had no further organ damage after one year of treatment.
However, others stress that ‘Benlysta’ is not a miracle drug and it only worked in 35 percent of North American patients tested and was not effective for patients with the deadliest form of the disease. According to them, it did not show positive results even in African Americans, who were disproportionately affected by the disease.
However, federal experts have voted in favour of the drug, setting aside concerns that the experimental therapy does not work in some key patient groups. European recommendation is a major milestone in the clinical development program for Benlysta while other regulatory applications are under review in other countries.
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