Horizon scanning for managing medicines

1. Horizon scanning for managing medicines Produced by UKMi to support the Prescribing Outlook series November 2007

2. Horizon scanning What is horizon scanning? Why is it necessary? How is it done? What will be the key pressures on medicines budgets in the NHS in 2007-2008?

3. What is horizon scanning? Horizon Scanning is defined by the Office of Science and Technology (OST) as:'the systematic examination of potential threats, opportunities and likely future developments, including (but not restricted to) those at the margins of current thinking and planning.'

4. Why horizon scan for medicines? • Manage budgets • Plan services - new and redesign • Anticipate pressures (financial and service delivery) • Identify areas for disinvestment • Manage entry into hospital/ formulary /practice etc • Be prepared! It’s better than fire fighting!

6. Drivers of growth in prescribing (1) • New drugs for diseases where previous therapeutic/ management options were limited e.g. rare genetic diseases, HPV vaccine • Ageing population • Expanded indications (increase in eligible population) e.g. chemotherapy drugs moving from last-line use to first-line use • Displacement of old drugs with new drugs at higher cost (accounts >60% of rise ) e.g. “biologicals” • New drugs added to standard therapy e.g. chemotherapy • Medicalisation e.g. anti-obesity drugs

7. Drivers of growth in prescribing (2) • National Service Frameworks • National Institute for Health and Clinical Excellence (NICE) • Quality and Outcomes Framework in primary care • SIGN, Scottish Medicines Consortium (SMC), All Wales Medicines Strategy Group (AWMSG)

8. Benefits of advance information • Enables assessment of safety & efficacy • Enables assessment of value or cost effectiveness (rarely) • Informs and primes NHS organisations to implement management strategies

9. Clinical opinion Patients & the public view NICE Directive Market authorisation ‘licence’ Prescribed for patients Local budgetary control Local formularies Clinical judgement New drugs and the NHS New product reviews Horizon scanning Health Technology assessments

10. The horizon scanning process systematic early identification ‘horizon scanning’ filtration and selection prioritisation assessment information retrieval dissemination Stage 1 Stage 2 Stage 3 Stage 4 Stage 5 Stage 6

11. systematic early identification ‘horizon scanning’ Stage 1 • Journals – specialist and general • General media • Specialist media for press releases highlighting • conference presentations • dates for submission to licensing authorities • plans for development • Industry • Licensing agencies • Clinical specialists • Other horizon scanners

12. filtration and selection Stage 2

13. information retrieval Stage 3 • Specialist databases • Company contacts, websites, annual reports • In-house files

14. prioritisation Stage 4

15. Group work 1Factors that influence impact • List factors that influence the impact a new drug/ licence extension/ new formulation might have. • Hint: Think about what drugs have had a large impact on your organisation over recent years and why this was so

16. Impact Factors (1) Financial factors • Cost of drug and administration • PbR • Will it change where patients are treated e.g. hospital vs healthcare at home vs primary care. • Funding of services?

17. Impact Factors (2) Drug properties/therapeutics • Anticipated licensed indication – is it wide or narrow? • Formulation and administration? • First in class? • Place in therapy? • Significant improvement in disease management? • What could be its USP (unique selling point)? • Other trials ongoing? (Licence extensions are easier to obtain and there may be off label use.)

18. Impact Factors (3) External factors • Size of target population i.e. large population or significant subset of large population? What is large? • Local services e.g. tertiary centre • Local use (in ongoing clinical trials or unlicensed use) • NHS priorities? • Where in NICE agenda? • Which company? GSK vs Valent • Local rep activity? • Patient groups • Media interest

19. Factors used by UKMi for prioritorisation The drug will be considered for inclusion in Prescribing Outlook if: • the drug is expected to provide a significant improvement in disease management • the drug is first in class or has a major new indication • there are limited other drug/non-drug alternatives • the drug cost will be high • the target population is large • there is likely to be a significant effect on service implications e.g. route/ formulation/ method of delivery • the drug or disease area is considered an NHS priority • the drug has significant additional indications in the advanced pipeline stage • the drug is in the EU licensing process • there is likely to be significant media interest.

20. Group work 2Prioritisation weighting • You have 6 drugs. Decide which 3 you need to highlight to your Trust. • You are given some information to help you decide. • Feedback with choice and reasons

21. assessment dissemination Finally ….. Stage 5 Stage 6

22. UKMi Horizon scanning products Stage 6

23. Key new drugs or licence extensions in 2007-08 • Dabigatran   • Rivaroxaban • Human papilloma virus vaccine • Vildagliptin  • Bevacizumab for non small cell lung cancer • Lapatinib • p53 protein  • Sorafenib for hepatocellular carcinoma • Thalidomide 

24. Oral anticoagulants (1) – Dabigatran and Rivaroxaban Anticipated launch 2008 Indication:for use in the prevention of deep vein thrombosis and pulmonary embolism after hip and knee prosthetic surgery. Impact? Primary and secondary care. • In 2005-06 in England about 218 per 100,000 people underwent prosthetic joint replacements; 60 - 90% of pts receive anticoagulant prophylaxis. • Oral anticoagulants will compete with low molecular weight heparins. • The impact will be in primary care where district nursing services will be freed from continued administration post discharge for course completion. • Licence for treatment of venous thromboembolism anticipated 2009.

25. Oral anticoagulants (2) – Dabigatran and Rivaroxaban Notes • Recent NICE guidance (Apr 07) states that: • Patients having elective orthopaedic surgery should be offered mechanical prophylaxis and either LMWH or fondaparinux • Patients having hip replacement surgery with one or more risk factors for VTE should have their LMWH or fondaparinux therapy continued for 4 weeks after surgery • Ximelagatran, an oral anticoagulant was launched some years ago in other EU countries. However, it was withdrawn worldwide last year due to concerns about hepatic adverse effects. Mild increases in LFTs have been associated with dabigatran and rivaroxaban.

26. Oral anticoagulants (3) – Dabigatran and Rivaroxaban Cost • Unknown. • Savings in district nursing services. • Savings in reduced monitoring will only be realised when these new agents are licensed for the same indications as warfarin e.g. stroke prevention in patients with atrial fibrillation. PIII trials are underway for this indication.

27. Human papilloma virus vaccine (1) Anticipated launch 2007 Indication:Prevention of cervical cancer. Impact? Primary care. • There are about 1,250 12-13yr old girls per 100,000 people in the UK. • A Department of Health programme will involve PCT Immunisation co-ordinators to facilitate implementation • Implementation will be complex as three doses are required involving liaison with schools and sexual and public health agencies.

28. Human papilloma virus vaccine (2) Notes • Will be routine HPV vaccination of girls aged 12 - 13 years starting from September 2008. • There will be a two-year catch up campaign starting in Autumn 2009, for girls up to 18 years. Cost • Cost will be funded centrally but is about £250 for a three dose course. • PCTs will plan how to deliver the programme locally but it will probably be through schools.

29. Vildagliptin (1) Anticipated launch 2007 Indication:Type 2 diabetes for use as dual therapy in combination with metformin, a sulphonylurea or a glitazone. Impact? Primary and secondary care. • The prevalence of Type 2 diabetes in England & Wales is about 2,500 per 100,000 people.

30. Vildagliptin (2) Notes • Dipeptidyl peptidase IV inhibitor, belonging to a new class of oral antidiabetic agents, the only other one currently available being sitagliptin. • Licence for vildagliptin will be broader than that for sitagliptin which is only licensed for dual therapy with metformin or a glitazone. • Recently reported adverse effects associated with glitazones may influence uptake of new agents. Cost • It will compete with other generically available second-line therapies. Likely to be similarly priced to sitagliptin (£433 per annum).

31. Bevacizumab Anticipated launch 2007 Indication:Metastatic non-squamous non-small cell lung cancer - first-line use. Impact? Secondary care. • The UK incidence of non-squamous non-small cell lung cancer (NSCLC) is about 32 per 100,000 people; 25-50% receive first-line chemotherapy (8 to 16 per 100,000 people). Notes • Bevacizumab will be add-on therapy for first-line use in this indication and would be used in advance of erlotinib or pemetrexed indicated for second-line treatment of all NSCLCs. Cost • Assuming an average 70kg pt receives a 15mg/kg every 3 weeks for 10 doses, additional drug cost will be £30,300 per patient.

32. Lapatinib Anticipated launch 2007 Indication:Metastatic breast cancer in HER2 positive patients – last-line treatment. Impact? Secondary care. • About 20% of pts with breast cancer overexpress HER2 indicating about 10 per 100,000 people may be eligible. • It may delay progression to palliative care. • Oral administration will limit service impact. Notes • In PIII trials for first-line use; a competitor to trastuzumab. Cost • Likely to be similar to other drugs in this field • Cost of overall treatment will increase as it will be used when other treatments have failed.

33. p53 protein Anticipated launch 2008 Indication: Head & neck cancer. Impact? Secondary care. • The incidence of head and neck cancer as a group ranges from 8 to 15 per 100,000 people. • Rates of the most common forms (mouth and larynx) are rising. Surgery is the main treatment. Notes • It is likely p53 protein will initially be available in 2007 for treatment of Li-Fraumeni syndrome, a rare genetic disorder. The licence for head and neck cancer will follow. • It will be the first gene therapy available in the EU. Cost • Unknown at this stage but as a gene therapy it is likely to be expensive.

34. Sorafenib Anticipated launch 2008 Indication: Advanced hepato-cellular carcinoma. Impact? Secondary care. • UK liver cancer incidence is 4-5 per 100,000 people with hepatocellular carcinoma being the most common form. Notes • Current options include surgery and transplantation but few patients are eligible; non-surgical options are less satisfactory. • Sorafenib could become first-line treatment. Cost • Cost of 400mg orally twice daily is over £2,500 per month.

35. Thalidomide Anticipated launch 2008 Indication: Multiple myeloma, first-line use. Impact? Secondary care. • UK incidence of multiple myeloma is 3 to 4 per 100,000 people. Notes • Thalidomide for first-line use would be additional to standard therapy. Currently, lenalidomide and bortezomib are licensed for second-line use. Cost • Current unlicensed cost assuming an average dose of 100mg daily is at least £5,000 pa. However, unlicensed cost may not reflect licensed cost. Lenalidomide costs about £52,000 pa.