What is the Big News?
The UK and the US have made a new agreement, called the UK-US Economic Prosperity Deal, which is a big change for how new medicines are bought and approved in the UK.
The main points are:
- Zero Tariffs for UK Exports: The US has agreed to not charge any extra taxes (called tariffs) on medicines and medical products made in the UK for at least three years. This is good news for UK pharmaceutical companies, as it makes it cheaper and easier for them to sell their products to the US.
- NHS Will Spend More on New Drugs: In return, the UK has promised to spend around 25% more on new, life-changing medicines for the NHS. This money will come from the government and is a commitment to invest more in innovative treatments.
Why the UK Becomes More Attractive for Drug Companies
This deal is a huge win for the companies that invent and make new drugs (the pharmaceutical industry). It makes the UK a much better place to invest money for two main reasons:
- Easier to Sell Medicines (Zero Tariffs)
- The US is the biggest buyer of medicines in the world. By removing tariffs (taxes) on UK medicines, the US is giving the UK a special advantage.
- The UK is now the only country to have this zero-tariff deal for medicine exports to the US.
- The Impact: This protects UK manufacturing jobs and encourages big global companies to build their factories or expand their business in the UK. They know they can now sell their products to the US more easily and cheaply from a UK base.
What is NICE and What is Changing?
The National Institute for Health and Care Excellence (NICE) is the group that decides whether a new treatment or medicine is worth the money for the NHS to use in England. They look at how much good a drug does (like giving people an extra year of good health) and how much it costs.
- NICE uses something called a cost-effectiveness threshold. This is the most the NHS is usually willing to pay for one extra year of good health that a medicine provides.
- For many years, this threshold was between £20,000 and £30,000 for one year of good health.
- The Change (Starting from April 2026): As part of the deal, this threshold will increase to between £25,000 and £35,000.
This is the first major increase in over 25 years.
What Does the Change Mean for Innovative Drugs?
This is the most important part for people with serious conditions like Spinal Muscular Atrophy (SMA).
- Better Access: Medicines that are very effective but also very expensive, like some of the new treatments for rare diseases, are often refused by NICE because they cost more than the old £20,000–£30,000 limit.
- New Approvals: Because the limit is higher (£25,000–£35,000), the NHS will now be able to pay more for these valuable drugs. NICE expects to approve around 3 to 5 more medicines each year that might have been rejected before, including treatments for rare diseases and some cancers.
- Faster Decisions: For conditions like SMA, which have very expensive but life-changing treatments, a higher threshold means these new drugs have a better chance of being approved for general use on the NHS, and potentially faster access for patients.
- Bringing Trials Here First: Companies usually start their clinical trials in countries where they believe the drug has the best chance of being approved and sold successfully afterwards. Because the UK is now a more attractive place to launch a drug (thanks to the higher NICE threshold), companies are more likely to run their early clinical trials here.
- Faster Trial Approvals: The UK Government has also worked to cut the time it takes to approve a clinical trial. When combined with the better business deal, this makes the UK highly competitive.
- Benefit to Patients: More clinical trials in the UK means that UK patients, especially those with conditions like SMA, get the chance to try new, ground-breaking treatments much earlier than they might otherwise.
In short, the new deal is designed to help UK medicine exports and, in return, the NHS has agreed to spend more on innovative medicines, which should make it easier for people with conditions like SMA to get hold of the newest and most effective treatments.
What happens to medicines being checked right now as is the case for nusinersen and risdiplam?
NICE has made a special plan for all the medicines they are currently reviewing (called ‘appraisals’). They want to make sure the change is fair and doesn’t cause too many delays.
The Plan for Ongoing Drug Checks
NICE has split the medicines they are currently checking into three main groups:
| Medicine Group | How the Old Rules (£20k–£30k) Apply | How the New Rules (£25k–£35k) Will Impact It |
| Group 1: Approved Anyway | The medicine is cheap enough and effective enough to be approved, even under the old lower limit. | Good News! NICE will continue as normal and recommend the drug for the NHS right away. No delay. |
| Group 2: The Borderline Cases | The medicine is too expensive for the old £30,000 limit, but it looks like it would be approved with the new, higher £35,000 limit. | Decision Paused! NICE will pause the final decision. They will wait until the new, higher limit is officially in place in April 2026. Then, they will approve it quickly without having to have a long meeting about it again. |
| Group 3: Still Too Expensive | The medicine is so expensive that it wouldn’t be approved even with the new, higher £35,000 limit. | Decision Made. The medicine will most likely get a negative recommendation (it won’t be recommended for the NHS). |
The goal is to get the best new treatments to patients as quickly as possible. The borderline cases (Group 2) are the ones that will benefit the most, as they now have a much better chance of being approved without being fully rejected first.
Other Important Questions Answered
- What about old decisions? Will NICE go back and approve medicines they rejected years ago?
No. The new rules only apply to brand new medicines or medicines that are already being checked right now. They won’t go back and change decisions they have already made, unless the company submits completely new evidence that the drug is more effective than they thought before.
Impact on Scotland, Wales, and Northern Ireland
Even though the government in Westminster (England) made the deal and NICE is based in England, the decision has a big influence across the whole of the UK.
| Nation | Who Checks the Medicines? | How the NICE Change Impacts Them |
| England | NICE (National Institute for Health and Care Excellence) | The change is direct and official. NICE will use the new higher limit of £25,000–£35,000 starting in April 2026. |
| Wales | AWMSG (All Wales Medicines Strategy Group) and NICE | Wales has a close relationship with NICE. They usually adopt (agree to use) almost all of NICE’s guidance. This means that, for most new drugs, Wales is expected to follow England and begin using the new, higher £25,000–£35,000 cost-limit as well. |
| Northern Ireland | Department of Health and NICE | Northern Ireland’s health department reviews NICE guidance and usually approves the majority of the recommendations. Like Wales, they are highly likely to adopt the new, higher cost-limit for new medicines. |
| Scotland | SMC (Scottish Medicines Consortium) | Scotland has its own separate group for checking drugs (the SMC). They do not use the same NICE cost-limit. However, the Voluntary Scheme for Branded Medicines—which is a deal between the UK government and drug companies about how much the NHS will spend on drugs—covers Scotland, Wales, and Northern Ireland too. This means:
1. Spending is linked: Because the whole UK is spending more on innovative medicines, drug companies are likely to keep bringing their new drugs to Scotland. 2. SMC may look again: The SMC has its own way of making decisions, but they will be aware that England is now willing to pay more for new, innovative treatments. This might encourage the SMC to be more flexible or generous when approving new, expensive medicines for Scottish patients. |
The Big Picture: Better Access for All
The main reason the UK Government made this deal was to encourage drug companies to bring their best new medicines to the UK as a whole.
- For Patients Everywhere: Because the price barrier has been raised in England (the biggest market), this makes the entire UK a more attractive place for global drug companies. This is expected to speed up patient access to medicines for rare conditions like SMA, not just in England, but also in Wales, Northern Ireland, and likely in Scotland too.
- A “UK-Wide” Investment: The commitment to invest 25% more in innovative treatments is a UK-wide policy. This means the extra funding to pay for these more expensive medicines should be available to health boards across all four nations.
In short, while the rules are only formally changing at NICE (England), the positive effect of allowing more expensive, high-tech drugs to be approved is expected to flow through to patients in every part of the United Kingdom.
Easier to Get Paid Well in the UK (NICE Threshold & Rebates)
- For years, companies worried that even if they created an amazing drug, the NHS might not pay enough for it because of the strict rules.
- Higher NICE Threshold: By raising the cost-limit for NICE approvals (from £20,000–£30,000 to £25,000–£35,000), the government is sending a clear message: “We are willing to pay more for truly innovative medicines.” This makes the UK a more valuable market for drug companies.
- Lower Rebates: The UK has also reduced a “tax” that drug companies have to pay back to the NHS if their sales are too high. This payback rate is being lowered and capped. This means the companies get to keep more of the money they make from selling the drugs, which gives them more reason to launch their new products in the UK first.
Find out more by watching the webinar from NICE here:
Changes to NICE’s cost-effectiveness thresholds next steps webinar – watch here
