Price Discount Prompts NICE to Approve Breast Cancer Drug 

Peter Russell

February 15, 2019

Roche made an improved price offer that persuaded the National Institute for Health and Care Excellence (NICE) to recommend pertuzumab (Perjeta) for routine NHS treatment of some women with HER2-positive breast cancer who have had surgery.

There was also guidance this week on limiting antimicrobial resistance when treating pneumonia, and advice on diagnosing Lyme disease without necessarily needing a blood test.

Pertuzumab for Adjuvant Treatment of Breast Cancer

NICE overturned previous negative assessments to recommend pertuzumab with intravenous trastuzumab (Herceptin, Roche) and chemotherapy, for the adjuvant treatment of human epidermal growth factor receptor2 (HER2)-positive early stage breast cancer in adults.

Patients would be eligible for treatment with the drug if they have lymph-node-positive disease, the new draft guidance said.

NICE estimated that 2700 people in this subgroup have a higher risk of their cancer returning.

Clinical trial evidence suggested that adding pertuzumab to trastuzumab and chemotherapy increased the proportion of people with node-positive disease whose disease did not spread. However, the appraisal committee said there was a lack of evidence on how long, if at all, it might increase survival.

The decision to recommend pertuzumab for routine NHS use in England followed an improved offer of a price discount by the manufacturer.

Roche also submitted a revised economic model which included only people with node-positive disease, whereas previous draft guidance also included patients who could not have hormonal therapy. This model was further tailored to use the appraisal committee's more conservative estimates of how long treatment benefit with pertuzumab would last.

Meindert Boysen, director of the Centre for Health Technology Assessment at NICE said: "We’re pleased that we’ve been able to work with the company to address the uncertainties of pertuzumab as a treatment for early HER2-positive breast cancer.

"Their response means that people who have a high risk of their cancer returning now have a new treatment option that could reduce the risk of that happening."

Mia Rosenblatt, assistant director of policy and campaigns at Breast Cancer Now, commented: "The fear of breast cancer returning or spreading can cause major anxiety for so many women, and it’s fantastic that adding Perjeta to trastuzumab and chemotherapy can now offer another step forward in reducing their risk of recurrence.

"Trastuzumab has been one of the greatest advances in treating breast cancer in recent decades, and it’s really exciting that adding Perjeta will stop the disease returning in even more women. Incremental advances like this will be absolutely vital to reaching our vision that by 2050, everyone who develops breast cancer will live – and live well.

"We hope that Wales, Northern Ireland, and Scotland will soon be able to follow suit in making Perjeta available for patients whose cancer has spread to their lymph nodes, and look forward to understanding the long-term benefits of this treatment combination."

Publication of final guidance is expected on 20th March 2019.

Brigatinib Recommended for Lung Cancer Treatment

Cost was a determining factor in NICE's decision to recommend the use of brigatinib (Alunbrig, Takeda) for treating ALK-positive advanced non-small-cell lung cancer after treatment with crizotinib (Xalkori, Pfizer).

An earlier appraisal consultation document said the drug was not cost-effective. However, the manufacturer has since improved its offer of a price discount.

People with this type of lung cancer are currently offered ceritinib (Zykadia, Novartis) as a second line treatment but in final draft guidance, NICE said it had taken into account clinical evidence to suggest that patients having brigatinib live longer than those having ceritinib.

Patients with ALK-(anaplastic lymphoma kinase) positive advanced NSCLC that have been treated with crizotinibare currently offeredceritinibas their nexttreatment.Clinical evidencebased on indirect comparisons of trialssuggeststhat people having brigatiniblive longer than those having ceritinib, and thatthey live longer beforetheir conditionworsens.

An improved commercial agreement from the company and further clarifications about its economic model mean it is now recommended for routine use in the NHS.

NICE estimated that fewer than 50 people in England would be eligible for this treatment, and that the number would reduce further because crizotinib is no longer considered the first-line treatment.

Final guidance is expected next month.

Lyme Disease Guidance

People with erythema migrans can be diagnosed with Lyme disease without the need for blood tests, NICE said in a draft quality standard.

The characteristic 'bull's eye' rash is present in approximately two-thirds of cases.

Professor Gillian Leng, deputy chief executive and director of health and social care at NICE, said: "For most people with Lyme disease, a course of antibiotics will be effective, so it is important we diagnose and treat people as soon as possible.

"A person with Lyme disease may present with a wide range of symptoms, so we have clear advice for professionals about the use of lab tests for diagnosis and the most appropriate antibiotic treatments. If a characteristic bull's eye rash is present, healthcare professionals should feel confident in diagnosing Lyme disease."

Veronica Hughes, CEO of the Caudwell LymeCo Charity, dedicated to fighting Lyme and associated diseases, said: "I hope the new quality standard will increase the number of doctors who feel confident diagnosing a Lyme disease rash on sight and treating the infection right away.

"Caudwell LymeCo Charity hears regularly from people whose doctors have diagnosed an erythema migrans but decide to check with a blood test, not realising that the rash is the more reliable of the two. Waiting for blood test results always delays treatment; when a patient has the rash, this delay is unnecessary and reduces the likelihood of total cure."

Saul Faust, professor of paediatric immunology and infectious diseases at the University of Southampton and chair of the guideline committee, said: "Lab tests are necessary when a person’s symptoms are unclear, but they are not needed if a person presents the characteristic red rash, erythema migrans.

"Doctors should feel confident to prescribe antibiotics immediately for those with erythema migrans."

In cases where Lyme disease is suspected but where no erythema migrans is present, GPs should offer an ELISA laboratory test and further investigations.

It is estimated that there are at least 3000 new cases of Lyme disease each year in the UK.

The draft quality standard is out for consultation until 12th March 2019.

Antimicrobial Prescribing for Pneumonia

Draft antimicrobial prescribing guidance was issued by NICE and Public Health England (PHE) on hospital-acquired and community-acquired pneumonia.

Both guidelines set out an antimicrobial prescribing strategy with the aim of optimising antibiotic use and reducing antibiotic resistance.

Guidance in the new drafts said that:

  • Antibiotics should be given to people with community- and hospital-acquired pneumonia within 4 hours of a diagnosis

  • Oral antibiotics should be given as a first-line treatment if the severity of their condition does not require intravenous antibiotics

  • Choice of antibiotics should be reviewed once results from any microbiological testing are available

  • A shorter course of antibiotics should be prescribed where appropriate, although the life-threatening nature of pneumonia should be taken into account

The new guidance provided detailed prescribing advice on hospital acquired infections that suggest treatment should be reviewed after 5 days and the antibiotic stopped if the person is clinically stable.

In cases of community-acquired infections, the new recommendations said that antibiotics should be stopped after 5 days unless the person is not clinically stable.

Paul Chrisp, director of the Centre for Guidelines at NICE, said: "In patients where there is a suspected case of pneumonia, it’s important that they are given the antibiotics they need as soon as possible. Microbiological testing helps determine what antibiotic will be most effective and helps limit antimicrobial resistance.

"These recommendations will provide healthcare professionals with advice on how to treat pneumonia effectively with antibiotics whilst also making responsible prescribing decisions to promote antimicrobial stewardship and preserve the future effectiveness of antibiotics."

Dr Susan Hopkins, deputy director of the National infection Service at PHE, added: "Rapid treatment of pneumonia is vital, but these new guidelines seek to refine the length of time that patients are using antibiotics in order to tackle resistance.

"By supporting clinicians to make treatment decisions based on the risk factors that impact the progression of pneumonia, we can encourage appropriate and targeted use of antibiotics."

Both drafts are out for consultation until 11th March 2019, and final guidance is expected in September.

Serious Eye Disorders

A quality standard was published by NICE on the diagnosis and treatment of serious eye disorders.

It covered cataracts, glaucoma, and age-related macular degeneration, and the prevention of sight loss. It described high-quality care in priority areas for improvement.

Among new additions to the guidance are that:

  • Adults with cataracts should not be refused surgery based on visual acuity alone

  • Adults with late age‑related macular degeneration (wet active) should start treatment within 14 days of referral to the macular service

  • Adults with serious eye disorders should be are given a certificate of vision impairment as soon as they are eligible

Hypertension in Pregnancy

A draft update to the hypertension in pregnancy guideline was issued which aims to bring recommendations in line with current practice.

The update includes advice on the management and treatment of hypertension during pregnancy, such as aiming for a target blood pressure of 135/85 mmHg or less, compared with the previous targets of below 150/80-100 mmHg.

GPs and specialists are also advised to discuss with the woman how to reduce their risk of future hypertensive disorders such as cardiovascular disease by maintaining a healthy lifestyle and weight.

Hypertension in pregnancy affects around 1 in 10 pregnancies.

Growing Old With a Learning Disability

NICE published a draft quality standard on the care and support of people growing older with a learning disability.

It outlined five priority areas for improvement, including the importance of people with a learning disability being actively involved in care and needs assessments, and of them having a meeting with hospital staff to discuss reasonable adjustments before planned hospital admissions.

NICE provided specialist support to two individuals with learning disabilities who sat on the committee developing the draft quality standard.

Another draft quality standard looked at how to make services work better for people with learning disabilities and behaviour that challenges.

Child Abuse and Neglect

NICE updated its quality standard on child abuse and neglect.

Areas covered include ensuring children and young people are encouraged to discuss their wellbeing if they display marked changes in behaviour or emotional state, and ensuring that those who have experienced abuse or neglect receive support from a consistent group of practitioners.

Hearing Loss

NICE published a draft quality standard on adult onset hearing loss.

Statements covered topics including referral for sudden hearing loss, hearing aids, and earwax removal.

The closing date for comments is 12th March 2019.

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