NICE Approves 'New Era' Ovarian Cancer Treatment

Nicky Broyd

July 26, 2019

A consultation on changes in its assessment methods and a decision on an ovarian cancer treatment feature in this week's roundup of announcements from the National Institute for Health and Care Excellence (NICE).

Ovarian Cancer

NICE approved the PARP inhibitor olaparib (Lynparza, AstraZeneca) for England's cancer Drugs Fund (CDF).

The twice a day tablets are for maintenance treatment of BRCA mutation-positive, advanced (stages 3 and 4) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who have responded to chemotherapy. This is the first targeted therapy it has approved for first-line maintenance for this group of patients. It has previously been used at a late stage but now may be given much earlier in the course of the disease.

The manufacturers said olaparib has helped nearly 60% of patients remain disease free after 3 years, compared with 27% on placebo.

NICE says around 700 patients a year in England could be eligible for the treatment which followed a new deal with the manufacturer.

Meindert Boysen, director of the NICE Centre for Health Technology Evaluation, said: "The availability of olaparib tablets as maintenance therapy is an important development in the management of BRCA mutation-positive advanced ovarian cancer. Olaparib is already used for ovarian cancer but is expected to have the greatest benefit when used early, and is considered to have the potential to cure the disease in some people if given before the first recurrence.

"We are pleased that the company has agreed a commercial arrangement for olaparib that will allow it to be made available immediately to people who currently have an unmet need for maintenance treatment."

NICE also quoted Dr Susana Banerjee, consultant medical oncologist at The Royal Marsden Hospital and team leader in gynaecological cancers at the Institute of Cancer Research. She was co-author on the SOLO-1 trial which developed evidence for the drug. "Maintenance treatment with olaparib heralds a new era for women with ovarian cancer," she said. "This is the first time we have seen such dramatic improvements in progression-free survival. This means that more women will have a longer time before relapse, time of chemotherapy and the possibility of increased survival.

"The landmark trial SOLO-1 led to a paradigm shift in the treatment of women with advanced ovarian cancer. This is the first trial of maintenance treatment with this type of drug for newly-diagnosed patients. The trial results to date have shown that olaparib maintenance therapy extends progression-free survival by around 3 years in women with BRCA mutation-linked advanced ovarian cancer. Some of my patients who have been treated in this trial at The Royal Marsden remain cancer-free several years later."

Also reacting to the decision in a statement, Cary Wakefield, chief executive of Ovarian Cancer Action, said the decision "has made personalised treatment a reality for women who have been newly diagnosed with BRCA-mutated ovarian cancer – a significant advancement in how we treat the disease. However, genetic testing is vital for women to access this treatment but despite Government guidelines, we know 29% of ovarian cancer patients are missing out. Addressing this inequality must be a Government priority to ensure women do not miss out on life-saving treatment."

Assessment Methods

NICE will review the methods it uses to develop its guidance on drugs, medical devices, and diagnostics assessments.

It will be talking to stakeholders about changes to the way it assesses costs, equality considerations, and reducing uncertainty where evidence is lacking.

In a statement, Sir Andrew Dillon, NICE chief executive, said: "This update is part of the regular review and refresh of our methods to ensure that they are robust and up-to-date.

"NICE is undertaking this review at a time of unprecedented change in the healthcare system, where developments such as personalised medicine, digitalisation of health, and use of cell and gene therapy, mean products are becoming ever more challenging to evaluate.

"Keeping NICE’s methods up-to-date is an important contribution to managing these changes."

People With Learning Disabilities

NICE issued two quality standards for people with learning disabilities.

The 2019 update to standards for behaviour that challenges included:

  • Local authorities and commissioning groups should appoint a lead person who would oversee strategic commissioning of services for all people with a learning disability

  • An annual health check from a GP should be provided and there should be a named lead practitioner

  • Families and carers should be involved in developing the care and support plan, including how to prevent or respond to a crisis

  • Specialist behavioural support should be provided in the community.

  • Patients should be supported to choose where and how they live

People growing older with a learning disability should:

  • Be actively involved in care and support needs assessments

  • Have a named lead practitioner

  • Have a plan for the future with at least an annual review

  • Have an annual health check

  • Meet hospital staff prior to any planned admission

Bladder Cancer

NICE said there were no major safety concerns over transurethral laser ablation for recurrent non-muscle-invasive bladder cancer. However, it cautioned that evidence over its efficacy is limited.

It called for further research and auditing into the procedure, and said patient selection should be carried out by a specialist bladder cancer multidisciplinary team.

Doctors planning such procedures should inform local clinical governance leads and patients and carers should be made aware of safety and efficacy uncertainty.

Uterine Fibroids

NICE said ultrasound-guided high-intensity transcutaneous focused ultrasound for symptomatic uterine fibroids should only be used in special circumstances due to limited evidence on efficacy and to recognised complications, including skin burns.

It said more research was needed and that procedures should be agreed with clinical governance leads. Patients, it said, should be made aware of limitations of the procedure and the risks of side effects.

Leukaemia

NICE recommended blinatumomab as a treatment option for Philadelphia-chromosome-negative CD19‑positive B‑precursor acute lymphoblastic leukaemia in adults. This is on condition of minimal residual disease of at least 0.1%, and only if the disease is in first complete remission. The guidance also relies on the manufacturer's commercial arrangements being in place.

Anyone already being treated with the drug can continue despite the new guidance.

NICE cited clinical evidence that blinatumomab may help increase the time between relapses and that it may lead to more patients being cured.

It cautioned about uncertainty due to a lack of direct comparisons between blinatumomab and continued chemotherapy, with or without haematopoietic stem cell transplantation.

Spinal Muscular Atrophy

NICE said nusinersen is recommended as an option for treating 5q spinal muscular atrophy (SMA) in certain circumstances: pre-symptomatic SMA, or SMA types 1, 2 or 3, and following the conditions of a managed access agreement.

The decision was made despite cost-effectiveness estimates being higher than normal. NICE acknowledged the estimates were difficult to interpret due to limited evidence of long-term benefits.

The recommendation will be reviewed as further evidence is gathered.

Peritoneal Carcinomatosis

In draft guidance, NICE said pressurised intraperitoneal aerosol chemotherapy for peritoneal carcinomatosis should only be used in the context of research. It said there are well recognised, serious side effects, and efficacy evidence is currently lacking.

The draft decision follows a rapid review of published literature.

Liver Colorectal Metastases 

In draft recommendations, NICE said selective internal radiation therapy for non-resectable colorectal metastases in the liver could be carried out in a research context.

There is some evidence the treatment could have quality of life benefits for patients who cannot tolerate chemotherapy.

The decision followed a rapid assessment of published literature.

COPD

On chronic obstructive pulmonary disease in over 16s, NICE reviewed evidence on inhaled triple therapy with long-acting muscarinic antagonists (LAMA) plus long acting beta agonists (LABA) plus inhaled corticosteroid (ICS) for managing stable COPD, and oral corticosteroids for managing exacerbations.

The update said that before starting LAMA+LABA+ICS, a clinical review should be conducted to ensure patients are offered help to quit smoking, and that their symptoms aren’t due to another health condition, such as heart failure. The decision to use triple therapy would depend on current therapy, and severity of exacerbations. Detailed records should be kept about the drugs used, including how effective they were, costs, side effects, and patient preferences.

The update on systemic corticosteroids was to offer oral prednisolone daily for 5 days where appropriate. The committee's reasons for recommending 5 days were the risks associated with long-term corticosteroid use and the lack of evidence of benefit from a course of longer than 7 days. In addition, shorter courses of 5 days are already in routine use.

Future Asthma Guidance

Future chronic asthma guidance will be for use UK-wide, NICE announced in a collaboration with the British Thoracic Society (BTS) and Scottish Intercollegiate Guideline Network (SIGN).

The collaboration should lead to a new 'asthma pathway' on diagnosing and managing asthma from childhood to adulthood.

Parkinson’s and Epilepsy Medication Recall

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a precautionary alert to patients taking rotigotine (Neupro, UCB Pharma) for Parkinson's disease and lacosamide (Vimpat, UCB Pharma) for epilepsy.

The MHRA said affected products are "believed to be legitimate" but there are concerns over them being withdrawn from the supply chain and then being reintroduced.

Affected batch numbers can be found on the websites of Kosei Pharma UK Ltd, MPT Pharma Ltd, Drugsrus Ltd/P.I.E. Pharma Ltd and Doncaster Pharmaceuticals Group Ltd.

In both cases patients are being told to keep taking their medication until they can talk to a healthcare professional.

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