Ofatumumab (Arzerra®) is accepted for restricted use within NHS Scotland.

[HAIRBEAR_UK]

Good news and well done CLL patients who gave time to give voice at the PACE meeting .

Ofatumumab (Arzerra)

Advice

following a full submission assessed under the orphan process

ofatumumab (Arzerra®) is accepted for restricted use within NHS Scotland.

Indication under review: ofatumumab in combination with chlorambucil or bendamustine is indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy.

SMC restriction: for use in patients who would not be considered for bendamustine therapy and who would receive chlorambucil-based therapy.

The combination of ofatumumab plus chlorambucil produced a statistically and clinically significant increase in progression free survival compared with an alkylating agent alone in older patients with previously untreated CLL who had co-morbidities.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of ofatumumab and it is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting

scottishmedicines.org.uk/SM...

SNIP: Press release/News 11/05/2015

SMC accepts medicines for leukaemia, ulcerative colitis and diabetes.

The Scottish Medicines Consortium (SMC) has today published advice accepting seven new medicines for use in NHS Scotland.

Two of these medicines, ofatumumab (Azerra) for the treatment of chronic lymphocytic leukaemia (CLL) (a cancer of the white blood cells) and idelalisib (Zy delig) for the treatment of follicular lymphoma (another type of blood cancer), were considered under SMC’s PACE (Patient and Clinician Engagement) process, which aims to improve patient access to new medicines for the treatment of end of life and very rare conditions.

Ofatumumab is used in combination with another cancer medicine, chlorambucil, to treat CLL in previously untreated patients who cannot receive therapy based on fludarabine. In the PACE meeting, patient groups and clinicians stated that the patients most likely to benefit from ofatumumab are those who are older, less fit and have co-morbidities. These patients are less able to tolerate more aggressive treatments and consequently have limited options. Ofatumumab also gives clinicians a wider choice and the ability to tailor therapy to individual patients. SMC restricted its use to those patients who would not be considered for treatment with bendamustine, and who would receive chlorambucil-based therapy.

SNIP: “SMC is pleased to be able to accept these new medicines which will benefit patients with a variety of conditions.

“Two of these medicines were considered under our PACE process, which allows us to apply greater flexibility in our decision making. It is now a year since we first introduced a range of new processes and the hard work of all those involved in helping to develop them – especially patient groups and clinicians – is beginning to show benefits for patients across Scotland through improved access to effective new medicines.”

Further details of all medicines can be found on our website, scottishmedicines.org.uk.

Notes for editors

1. The purpose of the Scottish Medicines Consortium (SMC) is to accept for use those newly licensed medicines that represent good value for money to NHSScotland.

2. SMC analyses information supplied by the submitting company on the health benefits of the medicine and justification of its price. Because the NHS has limited resources, SMC works to make sure that those medicines which represent good value for money are accepted for use as quickly as possible so that they can benefit patients.

3. The Consortium is made up of clinicians and pharmacists together with representatives of health boards, the pharmaceutical industry and the public. SMC is part of Healthcare Improvement Scotland.

4. The SMC assessment for each new product considers the following:

• the efficacy and safety profile of the medicine

• which patients would benefit from it

• how effective and safe it is relative to treatments being used at present

• what it costs relative to the other treatment options

5. Following the Scottish Government’s review into access to newly licensed medicines, from April 2014 SMC introduced more flexible approaches to the evaluation of medicines used at the end of life and for very rare conditions (orphan and ultra orphan medicines).

6. The new processes include the option of a Patient and Clinician Engagement (PACE) meeting, which can be requested by the submitting company. This gives patient groups and clinicians a stronger voice in SMC decision making. In addition, the assessment process for ultra-orphan (very rare) medicines will involve a broad decision-making framework which allows the Committee to consider the wider impact a medicine may have for patients and their carers beyond direct health benefits and also its impact on specialist services and costs to the NHS and Personal Social Services.

7. Including the medicines announced today, 15 medicines for end of life and rare conditions have so far been accepted for use in Scotland under the PACE process. Five have not been recommended.

8. SMC may be unable to accept a medicine for use in Scotland if the Committee is not satisfied that the benefits of the medicine represent an efficient use of NHS resources. This also applies to medicines considered under the PACE process. Circumstances in which the SMC may issue “not recommended” advice for medicines which have gone through the PACE process include:

- Where there is a high degree of uncertainty about the clinical benefits associated with the medicine

- A high likelihood that the medicine has extremely poor cost-effectiveness

- Where the submitting company has not engaged effectively with the SMC process.

9. A Patient Access Scheme (PAS) is a scheme proposed by a pharmaceutical company in order to improve cost effectiveness of a drug and enable patients to receive access to cost effective, innovative medicines. A Patient Access Scheme Assessment Group (PASAG) established under the auspices of NHS National Services Scotland reviews and advises NHS Scotland on the feasibility of proposed schemes for implementation. PASAG operates separately from SMC.

10. The standard measure of cost-effectiveness used by the SMC is the cost per Quality Adjusted Life Year (QALY). The QALY is a widely used economic indicator, or tool, that allows a consistent approach to comparing the value of different medicines. A QALY takes into account how a treatment affects a patient’s

• quantity of life (how long you live for)

and

• quality of life (the quality of your remaining years of life).

The QALY combines both these factors into a single measure that puts a figure on the health benefits for any medical treatment, including medicines. QALYs provide a benchmark that we can use to measure and compare the benefits that each medicine is likely to offer.

11. For medicines that have been not recommended by SMC, all NHS boards have procedures in place to consider individual requests when a doctor feels the medicine would be right for a particular patient. SMC advises the submitting company why a medicine has been not recommended and is pleased to receive any resubmission.

12. For further information and to view the complete advice for the medicines listed above, visit our website at: scottishmedicines.org.uk.