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Update on the substitution of medicines in the event of shortages

Following the governments January publication of a policy paper on obtaining medications in the event of no deal Brexit, we would like to alert Keep Me Informed users to the conditions and medicines where substitution of medicines should be approached with caution.

The government stated that around three-quarters of the medicines and over half the devices and one-use medical products (such as syringes) that the NHS uses, come into the UK via the EU.

'The government has analysed the supply chain, made plans to reduce the risk of disruption, and given instructions to pharmaceutical companies to ensure that they have adequate stocks to cope with any potential delays at the border.'

Anti epileptic treatments are one group where consistent use of the same prescribed medicine is required.

Other considerations are where medicines should be prescribed by brand name. For example, all biologicals should be prescribed by brand name.

This is due to a variety of factors such as:
  • bioavailability differences
  • modified-release characteristics
  • formulation difference of effect
  • patient familiarity
  • different licensed indications
The UK Medicines Information group published guidance in 2017. A link to this document is available in the main article (click on this headline to access).

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NICE approve tisagenlecleucel (Kymriah▼) for use in treating lymphoma under Cancer Drug Fund

The National Institute for Health and Care Excellence (NICE) has approved the use of Novartis' lymphoma treatment tisagenlecleucel, brand name Kymriah.

Kymriah is recommended for use within the Cancer Drugs Fund as an option for treating relapsed or refractory diffuse large B-cell lymphoma in adults after 2 or more systemic therapies and only if the conditions in the managed access agreement are followed.

Managed access schemes are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

NICE state that:

'More evidence on tisagenlecleucel is being collected, until June 2023. After this NICE will decide whether or not to recommend it for use on the NHS and update the guidance. It will be available through the Cancer Drugs Fund until then.

If you are not eligible for tisagenlecleucel therapy but are already having it, you should be able to continue until you and your doctor decide when best to stop.'

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Public Health England launches 'Cervical Screening Saves Lives' campaign

Public Health England have launched on a new drive to encourage women to ensure they undertake cervical screening.

The PHE campaign is designed to boost the number of women taking screening tests after attendance levels reached a 20-year low.

PHE state that 1 in 4 women are not undertaking screening even though they are entitled to. The campaign will encourage women to respond to their cervical screening invitation letter, and if they missed their last screening, to book an appointment at their GP practice.

Around 2,600 women are diagnosed with cervical cancer in England each year, and around 690 women die from the disease, which is 2 deaths every day. It is estimated that if everyone attended screening regularly, 83% of cervical cancer cases could be prevented.

New research from PHE shows that nearly all women eligible for screening (90%) would be likely to take a test that could help prevent cancer - and of those who have attended screening, 9 in 10 (94%) would encourage others who are worried to attend their cervical screening. Despite this, screening is at a 20-year low, with 1 in 4 eligible women (those aged 25 to 64) in the UK not attending their test.

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Keep Me Informed - Conditions and medicines added in January and February 2019

The following conditions have been added to Keep Me Informed since January 1st 2019.
  • Measles
  • Mumps
  • Rubella
  • Primary immunodeficiency disorders (PID)
  • Batten's disease (Neuronal ceroid lipofuscinosis)
  • Chronic myelomonocytic leukemia (CMML)
  • Chronic fatigue syndrome (ME)
  • Pruritis
  • Priapism
  • Liposarcoma
  • Pre-eclampsia
  • Photosensitivity reactions including solar urticaria, chemical photosensitization and polymorphous light eruption
For information about medicines added, NICE guidelines, and patient safety warnings, please see the full article.

You can follow any of these conditions using Keep Me Informed, which provides users with updates about the conditions they are interested in, including updates to NICE guidelines, patient leaflets, risk management materials, information from medicine regulators and clinical trial information. To track information about these conditions please use the 'Select conditions' button.

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NICE guidance recommending abemaciclib (Verzenios▼, Lilly) in treating breast cancer

The National Institute for Health and Care Excellence (NICE) has published guidance for Lilly's breast cancer treatment abemaciclib (brand name Verzenios) with another medicine, an aromatase inhibitor, for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer.

NICE state that 'Abemaciclib with an aromatase inhibitor is recommended as an option for treating breast cancer that is:
  • locally advanced or metastatic - the cancer is 'advanced' at the original site or has spread to other parts of the body
  • hormone receptor-positive - the cancer cells grow in response to the hormone oestrogen or progesterone
  • human epidermal growth factor receptor 2 (HER2)-negative - where the cancer cells lack the HER2 protein on their surface. HER2 helps control cell growth.
NICE have approved abemaciclib for treating breast cancer as first line endocrine-based therapy in adults.

Abemaciclib is recommended only if the manufacturer provides it according to the commercial arrangement.

Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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NICE publish draft guidelines recommending use of pertuzumab (Perjeta, Roche) in the early treatment breast cancer

The National Institute for Health and Care Excellence (NICE) has published final draft guidance for Roche's breast cancer treatment pertuzumab (brand name Perjeta) for treating early HER2-positive breast cancer in people whose disease has spread to their lymph nodes. .

NICE state that 'this positive recommendation is for people who have had surgery for their breast cancer and whose cancer has already spread to their lymph nodes. The estimated 2700 people in this subgroup have a higher risk of their cancer returning.

The evidence shows that adding pertuzumab to trastuzumab and chemotherapy after surgery increased the proportion of people whose disease didn’t spread. However, there is a lack of evidence on how long, if at all, adding pertuzumab might increase the overall length of time people live.'

Pertuzumab, with intravenous trastuzumab and chemotherapy, is recommended for the adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer in adults, only if:
  • they have lymph-node-positive disease
  • the company provides it according to the commercial arrangement
Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

A final decision is expected to be published on 20th March 2019.

For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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MHRA drug safety update for carbimazole

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a drug safety update for the hyperthyroidism treatment carbimazole. The update states that cases of acute pancreatitis have been reported very infrequently during treatment with carbimazole

Acute pancreatitis is a condition where the pancreas becomes inflamed (swollen) over a short period of time.

The pancreas is a small organ, located behind the stomach, that helps with digestion.

Symptoms of acute pancreatitis include:
  • suddenly getting severe pain in the centre of your tummy (abdomen)
  • feeling or being sick
  • diarrhoea
  • a high temperature of 38C or more (fever)
The MHRA advice is:
  • if acute pancreatitis occurs, stop carbimazole treatment immediately
  • do not use carbimazole in patients with a history of acute pancreatitis in association with previous treatment
  • re-exposure may result in life-threatening acute pancreatitis with a decreased time to onset
  • report suspected adverse drug reactions to the Yellow Card Scheme immediately
For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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NICE publish draft guidance recommending use of brigatinib (brand name Alunbrig▼) for the treatment of lung cancer

The National Institute for Health and Care Excellence (NICE) has published final draft guidance for Takeda's lung cancer treatment brigatinib (brand name Alunbrig) for treating liver cancer.

NICE state that 'brigatinib is recommended, within its marketing authorisation, for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have already had crizotinib. It is recommended only if the company provides it according to the commercial arrangement.'

Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.

This means that Alunbrig will be available for use by NHS England and Wales when the determination is published in March 2019.

For more information see full article.

You can follow this medicine using our Medicines Tracker service which provides users with updates about the medicines they are interested in, including updates to Patient Leaflets, information from medicine regulators and clinical trial information. To track information about this medicine please click on this article and follow the 'About this medicine' link then select 'Follow medicine'.

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