NHS uptake of NICE-approved medicines varies according to location and disease area, according to the Health and Social Care Information Centre (HSCIC).

The HSCIC report shows that for 13 disease areas where comparison was possible, use of NICE-approved drugs was above the expected level in six and below it in six.

Roche’s cancer drug Herceptin (trastuzumab) was among several medicines whose prescription level was lower than expected.

Comparisons between NHS organisations indicate regional variation.

However, HSCIC Chief Executive Tim Straughan said: “Anyone interpreting the figures needs to be clear about the limitations of what the data show and it would certainly be wrong to think they definitively show drugs are being either ‘under’ or ‘over’ prescribed.”

Medicines whose uptake was higher than expected included carmustine implants and temozolomide (for brain cancer), varenicline (for smoking cessation), insulin glargine and detemir (for type 1 diabetes), statins (for high cholesterol) and drugs for osteoporosis.

Medicines whose uptake was lower than expected included riluzole (for MND), naltrexone (for heroin addiction), trastuzumab (for breast and gastric cancer), prucalopride (for chronic constipation), febuxostat (for gout) and drugs for acute coronary syndrome.

Steve Oldfield, Managing Director UK & Ireland of Sanofi, commented: “Many of the medicines appraised by NICE which are absent from the report are not reaching patients as quickly as they should, as local funding pressures in the NHS start to bite.

“More worryingly still, the very latest medicines launched in the last two years are being used significantly less than expected.”

Mylan has launched a generic version of Roche’s Bonviva tablets for the treatment of osteoporosis.

The Ibandronic Acid Film Coated Tablets have been released on the day the patent for Bonviva expired.

Didier Barret, Mylan EMEA President, said the manufacturer is “excited” to add the tablets to its portfolio of more than 350 products in the UK.

The treatment is used in postmenopausal women with osteoporosis who are at an increased risk of fracture.

The drug had sales of around £7.5 million in the UK for the year ending March 2012, according to IMS Health.

Mylan, the first company to launch a generic Ibandronic Acid formulation in the UK, recently launched the product in Spain after Bonviva’s protection expired there.

The benefits of hormone replacement therapy (HRT) for women who take it within 10 years of menopause outweigh the risks, according to study reviews.

HRT was found to reduce the incidence of heart disease, fractures and ongoing menopausal symptoms.

The study reviews published by the International Menopause Society further challenge the interim conclusion of the Million Women Study (MWS) ten years ago that HRT is too dangerous.

The increased risks of breast cancer, stroke and heart disease suggested by the MWS have since been disproved by retrospective analysis of its data.

HRT, which replaces oestrogen and progesterone in post-menopausal women, has improved the health and fitness of millions of patients.

The MWS findings led to HRT being largely abandoned – but later analysis found the study was methodologically flawed and the risks related mainly to women who started taking HRT long after the menopause.

The new reviews conclude that a ‘window of opportunity’ exists for HRT if it is started within 10 years of menopause or before age 60.

The therapy has been shown to significantly reduce the risks of osteoporosis, heart disease and colorectal cancer, while only slightly increasing the risks of embolism and stroke.

HRT is more effective than statins or aspirin in overall effect on mortality, the reviews concluded.

Investigator JoAnn Manson of Harvard Medical School commented: “HRT is not appropriate for every woman, but it may be appropriate for many women.”

The European Medicines Agency (EMA) has recommended label changes to Servier’s osteoporosis drugs Protelos and Osseor to include new contraindications and revised warnings.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that the drugs are an important treatment for women with osteoporosis, but that the associated risks need better management.

The CHMP no longer recommends Protelos and Osseor (strontium ranelate) for use in immobilised patients or patients with venous thromboembolism (VTE), and has recommended an update of the warnings regarding serious skin reactions.

Both drugs are indicated for the treatment of osteoporosis in postmenopausal women to reduce the risk of hip and spine fractures.

The review followed the publication of a French study that identified 199 severe adverse reactions to these medicines between January 2006 and March 2009. Around half were VTE events and around a quarter were skin reactions.

The risk of VTE was identified in clinical trials, and the risk of severe skin reactions had been reported from patient experience. These risks were already noted in the product information.

The CHMP has reviewed all available data on the safety of Protelos and Osseor and recommended:

• Doctors should not prescribe these drugs for patients with VTE or a history of VTE, or to patients who are immobilised. Patients in these categories should discuss their treatment with their doctor at their next scheduled appointment.

• Doctors should re-evaluate the need to continue treatment with Protelos or Osseor in patients over 80 years of age at risk of VTE.

• Prescribers should make patients aware of the time-to-onset and likely signs and symptoms of severe skin reactions. Patients should stop treatment immediately if such symptoms occur, and not resume at any time.

A major observational study that was widely accepted as proof that hormone replacement therapy (HRT) increases the risk of breast cancer has been challenged following a new review of the evidence.

The Million Women Study (MWS), which has driven a major drop in the number of menopausal and post-menopausal women being prescribed HRT, did not prove a causal link between HRT and breast cancer and its conclusions were ‘biologically implausible’, the review found.

The British Medical Journal (BMJ) recently claimed the reduction in prescription of HRT had reduced the incidence of breast cancer in the UK – so the review will give many GPs pause for thought.

The MWS analysed new cases of breast cancer arising in women who reported for breast screening in the UK between 1966 and 2001. It concluded that HRT increased the risk of fatal breast cancer by 22%.

The impact of the MWS on NHS prescribing and public perception has been drastic, with some clinicians demanding the banning of HRT while others have argued strongly for its retention as a treatment option for osteoporosis.

The review, published in the Journal of Family Planning and Reproductive Health Care (a BMJ Group journal) used scientific criteria to review the findings of the MWS and highlighted a number of flaws in the study’s design, including:

• Cancers detected in the first few months of the study would have been present beforehand, but these participants were not excluded.

• The use of study participants already reporting for breast screening would have increased the participation of HRT users (and non-HRT users) already aware of potential breast cancer symptoms.

• In a later MWS report, follow-up data on HRT use was not available for over 50% of the study participants.

In addition, the review argued that a 22% increase in the risk of fatal breast cancer due to HRT within the short time frame of the study was “biologically implausible”.

“The name ‘Million Women Study’ implies an authority beyond criticism or refutation. Yet the validity of any study is dependent on the quality of its design, execution, analysis and interpretation,” said the review authors.

The “problems and uncertainties” of the MWS as an observational study meant that its evidence was “unreliable”, they concluded, and so “the only effect of its massive size would have been to confer spurious statistical authority to doubtful findings.”

A review has begun into the benefit-risk profile and the conditions of use of Servier’s Protelos (pictured) and Osseor following cases of venous thromboembolism (VTE) and drug rash with eosinophilia and systemic symptoms (DRESS).

The EMA is now analysing strontium-ranelate-containing osteoporosis medicines after links to cardiovascular and cutaneous events were found.

The CHMP says it is now reviewing all relevant data into the links before making a decision whether to change the benefit-risk balance of the medications.

Protelos and Osseor were authorised via the centralised procedure in September 2004 and are indicated for the treatment of postmenopausal osteoporosis to reduce the risk of vertebral and hip fractures.

The EMA says that VTE and DRESS are known risks of these medicines and are addressed in the risk management plan and have been closely reviewed by the CHMP since their authorisation.

A study analysing the side effects associated with strontium-ranelate-containing medicines noted that there were 199 severe adverse reactions between January 2006 and March 2009. More than half of these (52%) were cardiovascular and more than a quarter (26%) were cutaneous.

The authors of the study concluded that DRESS is unpredictable but the VTE risk could be reduced by adding a contraindication for patients with a risk of cardiovascular risks and by stopping treatment if a new risk occurs.

Based on recent pharmacovigilance update and pending an European review, the French competent authority Afssaps have advised restricting the use of medication including strontium ranelate to patients who are under 80 years of age, at high risk of fractures and who cannot take bisphosphonates.

The FDA has approved Amgen’s osteoporosis drug Prolia for the treatment of bone loss associated with certain chemotherapy.

The medicine is the first for cancer treatment-induced bone loss, now indicated for women receiving adjuvant aromatase inhibitor therapy for breast cancer and men with prostate cancer who are being treated with hormone therapy.

The denosumab drug is known to reduce fracture risks in breast cancer patients taking drugs that halt oestrogen production and prostate cancer patients treated with androgen-deprivation therapies.

Matthew Smith, Director of the Genitourinary Malignancies Programme at Massachusetts General Hospital Cancer Center in Boston, said: “Bone loss and fractures are recognised adverse effects of hormone ablation therapies but we have not had an approved treatment option to prevent these problems for our patients”.

Prolia was previously approved in 2010, intended to be used in post-menopausal women with osteoporosis who were at increased risk of fractures.

Both therapies reduce hormone levels, leading to increased risk of bone loss and fracture.

Denosumab is also the active ingredient in Amgen’s Xvega, which is designed to prevent fractures in patients with cancer that has spread to the bone.

Denosumab is the first in a new class of medicines that blocks proteins that activate bone-destroying cells called osteoclasts.

The FDA has approved Amgen’s osteoporosis drug Prolia for the treatment of bone loss associated with certain chemotherapy.

The medicine is the first for cancer treatment-induced bone loss, now indicated for women receiving adjuvant aromatase inhibitor therapy for breast cancer and men with prostate cancer who are being treated with hormone therapy.

The denosumab drug is known to reduce fracture risks in breast cancer patients taking drugs that halt oestrogen production and prostate cancer patients treated with androgen-deprivation therapies.

Matthew Smith, Director of the Genitourinary Malignancies Programme at Massachusetts General Hospital Cancer Center in Boston, said: “Bone loss and fractures are recognised adverse effects of hormone ablation therapies but we have not had an approved treatment option to prevent these problems for our patients”.

Prolia was previously approved in 2010, intended to be used in post-menopausal women with osteoporosis who were at increased risk of fractures.

Both therapies reduce hormone levels, leading to increased risk of bone loss and fracture.

Denosumab is also the active ingredient in Amgen’s Xvega, which is designed to prevent fractures in patients with cancer that has spread to the bone.

Denosumab is the first in a new class of medicines that blocks proteins that activate bone-destroying cells called osteoclasts.

The FDA has approved Amgen’s osteoporosis drug Prolia for the treatment of bone loss associated with certain chemotherapy.

The medicine is the first for cancer treatment-induced bone loss, now indicated for women receiving adjuvant aromatase inhibitor therapy for breast cancer and men with prostate cancer who are being treated with hormone therapy.

The denosumab drug is known to reduce fracture risks in breast cancer patients taking drugs that halt oestrogen production and prostate cancer patients treated with androgen-deprivation therapies.

Matthew Smith, Director of the Genitourinary Malignancies Programme at Massachusetts General Hospital Cancer Center in Boston, said: “Bone loss and fractures are recognised adverse effects of hormone ablation therapies but we have not had an approved treatment option to prevent these problems for our patients”.

Prolia was previously approved in 2010, intended to be used in post-menopausal women with osteoporosis who were at increased risk of fractures.

Both therapies reduce hormone levels, leading to increased risk of bone loss and fracture.

Denosumab is also the active ingredient in Amgen’s Xvega, which is designed to prevent fractures in patients with cancer that has spread to the bone.

Denosumab is the first in a new class of medicines that blocks proteins that activate bone-destroying cells called osteoclasts.

NICE has published a proposed ‘menu’ of Quality and Outcomes Framework (QOF) indicators for 2012/2013.

The proposed list includes three new indicators for the support and treatment for smokers, two to assess physical activity, one for asthma, plus a set on fragility fractures in osteoporosis patients.

Christine Carson, Programme Director of NICE’s Centre for Clinical Practice, says the indicators have already been tested “to make sure they work”.

The Framework is a voluntary incentive scheme that rewards GP practices for improvements in the quality of care for patients.

Introduced in 2004, NICE took over the management of arranging the development and review of indicators in April 2009.

The Institute has recommended that 12 existing indicators be retired, including three for depression and two for diabetes, and also advised replacing a further four.

The selection of the final indicators for inclusion within the Framework will be decided by NHS Employers, on behalf of the UK health departments, and the General Practitioners Committee (GPC) of the British Medical Association (BMA) and published later in the year.